Colon and Rectal

A 70-year-old man underwent salvage therapy for multiple myeloma (MM). While on maintenance immunotherapy he developed a sternal plasmacytoma. After the fifth cycle of treatment, he developed swelling, erythema, and pain in his right testis.

The main differential diagnoses for those symptoms are infections and tumors; infection is more common, so his clinicians at Indiana University School of Medicine presumed orchitis and started him on IV antibiotics. The pain resolved, but the swelling persisted after the antibiotic course. The clinicians turned to biochemical marker screening for germ cell tumors, but those were negative. Serial ultrasound imaging, which they had begun during his admission, remained unchanged.

Meanwhile, the patient’s chemotherapy was being held back, and he developed another sternal mass, prompting a fluorodeoxyglucose-positron emission tomography–computed tomography (PET/CT) scan to evaluate for relapse of myeloma. The scan revealed an enlarged, diffusely hypermetabolic right testicle. Believing the symptoms were related to the myeloma and not orchitis, the clinicians advised a radical orchiectomy.

A biopsy after the surgery showed tumor cells consistent with testicular plasmacytoma.

While rare, testicular plasmacytoma is commonly associated with MM, especially in the later stages, when cancer cells are more aggressive and not relying on bone marrow for survival, the clinicians say. Unlike myeloma, which typically spreads via blood to bone sites, testicular plasmacytoma may spread via lymphatic channels to the regional lymph nodes and subsequently to distant sites, the clinicians add, similarly to lymphoma or germ cell tumor.

It is hard to diagnose, though. The clinicians say the patient’s case illustrates the challenges. Imaging studies such as ultrasound and CT scans are not specific. And although FDG-PET/CT imaging is a standard staging tool for myeloma and helpful in identifying plasmacytoma when evidenced as intramedullary or extramedullary hypermetabolic lesions, hypermetabolic lesions are not always malignant, they note. FDG-PET/CT can’t differentiate between orchitis and testicular plasmacytoma.  Biopsy remains the diagnostic gold standard.

Source:
Schiavo C, Mann SA, Mer J, Suvannasankha A. BMJ Case Rep. 2018;pii:bcr-2017-222046.
doi: 10.1136/bcr-2017-222046.

A 70-year-old man underwent salvage therapy for multiple myeloma (MM). While on maintenance immunotherapy he developed a sternal plasmacytoma. After the fifth cycle of treatment, he developed swelling, erythema, and pain in his right testis.

The main differential diagnoses for those symptoms are infections and tumors; infection is more common, so his clinicians at Indiana University School of Medicine presumed orchitis and started him on IV antibiotics. The pain resolved, but the swelling persisted after the antibiotic course. The clinicians turned to biochemical marker screening for germ cell tumors, but those were negative. Serial ultrasound imaging, which they had begun during his admission, remained unchanged.

Meanwhile, the patient’s chemotherapy was being held back, and he developed another sternal mass, prompting a fluorodeoxyglucose-positron emission tomography–computed tomography (PET/CT) scan to evaluate for relapse of myeloma. The scan revealed an enlarged, diffusely hypermetabolic right testicle. Believing the symptoms were related to the myeloma and not orchitis, the clinicians advised a radical orchiectomy.

A biopsy after the surgery showed tumor cells consistent with testicular plasmacytoma.

While rare, testicular plasmacytoma is commonly associated with MM, especially in the later stages, when cancer cells are more aggressive and not relying on bone marrow for survival, the clinicians say. Unlike myeloma, which typically spreads via blood to bone sites, testicular plasmacytoma may spread via lymphatic channels to the regional lymph nodes and subsequently to distant sites, the clinicians add, similarly to lymphoma or germ cell tumor.

It is hard to diagnose, though. The clinicians say the patient’s case illustrates the challenges. Imaging studies such as ultrasound and CT scans are not specific. And although FDG-PET/CT imaging is a standard staging tool for myeloma and helpful in identifying plasmacytoma when evidenced as intramedullary or extramedullary hypermetabolic lesions, hypermetabolic lesions are not always malignant, they note. FDG-PET/CT can’t differentiate between orchitis and testicular plasmacytoma.  Biopsy remains the diagnostic gold standard.

Source:
Schiavo C, Mann SA, Mer J, Suvannasankha A. BMJ Case Rep. 2018;pii:bcr-2017-222046.
doi: 10.1136/bcr-2017-222046.

A 70-year-old man underwent salvage therapy for multiple myeloma (MM). While on maintenance immunotherapy he developed a sternal plasmacytoma. After the fifth cycle of treatment, he developed swelling, erythema, and pain in his right testis.

The main differential diagnoses for those symptoms are infections and tumors; infection is more common, so his clinicians at Indiana University School of Medicine presumed orchitis and started him on IV antibiotics. The pain resolved, but the swelling persisted after the antibiotic course. The clinicians turned to biochemical marker screening for germ cell tumors, but those were negative. Serial ultrasound imaging, which they had begun during his admission, remained unchanged.

Meanwhile, the patient’s chemotherapy was being held back, and he developed another sternal mass, prompting a fluorodeoxyglucose-positron emission tomography–computed tomography (PET/CT) scan to evaluate for relapse of myeloma. The scan revealed an enlarged, diffusely hypermetabolic right testicle. Believing the symptoms were related to the myeloma and not orchitis, the clinicians advised a radical orchiectomy.

A biopsy after the surgery showed tumor cells consistent with testicular plasmacytoma.

While rare, testicular plasmacytoma is commonly associated with MM, especially in the later stages, when cancer cells are more aggressive and not relying on bone marrow for survival, the clinicians say. Unlike myeloma, which typically spreads via blood to bone sites, testicular plasmacytoma may spread via lymphatic channels to the regional lymph nodes and subsequently to distant sites, the clinicians add, similarly to lymphoma or germ cell tumor.

It is hard to diagnose, though. The clinicians say the patient’s case illustrates the challenges. Imaging studies such as ultrasound and CT scans are not specific. And although FDG-PET/CT imaging is a standard staging tool for myeloma and helpful in identifying plasmacytoma when evidenced as intramedullary or extramedullary hypermetabolic lesions, hypermetabolic lesions are not always malignant, they note. FDG-PET/CT can’t differentiate between orchitis and testicular plasmacytoma.  Biopsy remains the diagnostic gold standard.

Source:
Schiavo C, Mann SA, Mer J, Suvannasankha A. BMJ Case Rep. 2018;pii:bcr-2017-222046.
doi: 10.1136/bcr-2017-222046.

WASHINGTON – Using hemostatic clips to close colonic mucosal defects following endoscopic removal of larger polyps cut the rate of delayed, severe bleeding episodes in half in a multicenter, randomized trial with 918 patients.

“The benefit appears limited to proximal polyps,” Heiko Pohl, MD, said at the annual Digestive Disease Week^®. In that prespecified subgroup, which included two-thirds of enrolled patients, placement of hemostatic clips on defects left after removing polyps 20 mm in diameter or larger cut the rate of delayed, severe bleeding by two-thirds, compared with patients with large defects not treated with clips. This result represented a number needed to treat with clips of 15 patients with large proximal polyps to prevent one episode of delayed severe bleeding, said Dr. Pohl, a gastroenterologist at the VA Medical Center in White River Junction, Vt.

Mitchel L. Zoler/MDedge News

Although the results that Dr. Pohl reported came from a trial that originally had been designed to generate data for Food and Drug Administration approval for using the clips to close defects following large polyp removal, the clips received approval for this indication from the agency in 2016 while the study was still in progress.

But Dr. Pohl maintained that the new evidence for efficacy that he reported will provide further impetus for gastroenterologists to use clips when they remove larger polyps in proximal locations. “I think this study will help standardize treatment of mucosal resections and change clip use,” he said in an interview.

“This was a terrific study, and one that needed to be done,” commented John R. Saltzman, MD, professor of medicine at Harvard Medical School and director of endoscopy at Brigham and Women’s Hospital in Boston. But Dr. Saltzman, who spoke from the floor during discussion of Dr. Pohl’s report, added that data on the average number of clips required to close defects were needed to assess the cost-effectiveness of the treatment, data that Dr. Pohl said were available but still being analyzed.

“We have to know how many clips to use and how to close the polyp,” Dr. Saltzman said. Dr. Pohl estimated that roughly four or five clips had been used per defect, but he cautioned that this estimate was preliminary pending his complete analysis of the data.

The CLIP (Clip Closure After Endoscopic Resection of Large Polyps) study enrolled patients with at least one nonpedunculated colonic polyp that was at least 20 mm in diameter at 16 U.S. centers, as well as one center in Montreal and one in Barcelona. The patients averaged 65 years of age, and 6%-7% of patients had more than one large polyp removed during their procedure. Randomization produced one important imbalance in assignment: 25% of the 454 patients in the clipped arm were on an antithrombotic drug (either an anticoagulant or antiplatelet drug) at the time of their endoscopy, compared with 33% of the 464 patients in the control arm.

The study’s primary endpoint was the incidence of “severe” bleeding within 30 days after the procedure. The study defined severe bleeding as an event that required hospitalization, need for repeat endoscopy, need for a blood transfusion, or need for any other major intervention, explained Dr. Pohl, who is also on the staff of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Such events occurred in 3.5% of the patients who underwent clipping and in 7.3% of control patients who received no clipping, a statistically significant difference (P = .01). Among patients with proximal polyps, the bleeding rates were 3.3% among clipped patients and 9.9% among controls, also a statistically significant difference. Among patients with distal polyps the bleeding rates were 4.0% among clipped patients and 1.4% among controls, a difference that was not statistically significant.

Dr. Pohl and his associates ran three other prespecified, secondary analyses that divided the enrolled patients into subgroups. These analyses showed no significant effect on outcome by polyp size when comparing 20-39 mm polyps with polyps 40 mm or larger, treatment with an antithrombotic drug, or method of cauterization. The median time to severe bleeding was 1 day among the controls and 7 days among the clipped patients.

Aside from the difference in rates of delayed bleeding, the two study arms showed no significant differences in the incidence of any other serious postprocedure events. The rates of these nonbleeding events were 1.3% among clipped patients and 2.4% among the controls.

The researchers ran all these analyses based on the intention-to-treat assignment of patients. However, during the study, 9% of patients assigned to the control arm crossed over ended up receiving clips during their procedure after all, a rate that Dr. Pohl called “surprisingly high,” whereas 14% of patients assigned to the clip arm never received clips. A per-protocol analysis that censored patients who did not receive their assigned treatment showed that, among the remaining patients who underwent their assigned treatment, the rate of delayed, severe bleeds was 2.3% among the 390 patients actually treated with clips and 7.2% among the 419 controls who never received clips, a statistically significant difference, he reported.

Dr. Pohl also noted that it was “somewhat surprising” that clipping appeared to result in complete closure in “only” 68% of patients who underwent clipping and that it produced partial closure in an additional 20% of patients, with the remaining patients having mucosal defects that were not considered closed by clipping.

The study was funded by Boston Scientific, the company that markets the hemostatic clip (Resolution 360) tested in the study. Dr. Pohl had no additional disclosures. Dr. Saltzman had no disclosures.

[email protected]

SOURCE: Pohl H et al. Digestive Disease Week, Presentation 886.

WASHINGTON – Using hemostatic clips to close colonic mucosal defects following endoscopic removal of larger polyps cut the rate of delayed, severe bleeding episodes in half in a multicenter, randomized trial with 918 patients.

“The benefit appears limited to proximal polyps,” Heiko Pohl, MD, said at the annual Digestive Disease Week^®. In that prespecified subgroup, which included two-thirds of enrolled patients, placement of hemostatic clips on defects left after removing polyps 20 mm in diameter or larger cut the rate of delayed, severe bleeding by two-thirds, compared with patients with large defects not treated with clips. This result represented a number needed to treat with clips of 15 patients with large proximal polyps to prevent one episode of delayed severe bleeding, said Dr. Pohl, a gastroenterologist at the VA Medical Center in White River Junction, Vt.

Mitchel L. Zoler/MDedge News

Although the results that Dr. Pohl reported came from a trial that originally had been designed to generate data for Food and Drug Administration approval for using the clips to close defects following large polyp removal, the clips received approval for this indication from the agency in 2016 while the study was still in progress.

But Dr. Pohl maintained that the new evidence for efficacy that he reported will provide further impetus for gastroenterologists to use clips when they remove larger polyps in proximal locations. “I think this study will help standardize treatment of mucosal resections and change clip use,” he said in an interview.

“This was a terrific study, and one that needed to be done,” commented John R. Saltzman, MD, professor of medicine at Harvard Medical School and director of endoscopy at Brigham and Women’s Hospital in Boston. But Dr. Saltzman, who spoke from the floor during discussion of Dr. Pohl’s report, added that data on the average number of clips required to close defects were needed to assess the cost-effectiveness of the treatment, data that Dr. Pohl said were available but still being analyzed.

“We have to know how many clips to use and how to close the polyp,” Dr. Saltzman said. Dr. Pohl estimated that roughly four or five clips had been used per defect, but he cautioned that this estimate was preliminary pending his complete analysis of the data.

The CLIP (Clip Closure After Endoscopic Resection of Large Polyps) study enrolled patients with at least one nonpedunculated colonic polyp that was at least 20 mm in diameter at 16 U.S. centers, as well as one center in Montreal and one in Barcelona. The patients averaged 65 years of age, and 6%-7% of patients had more than one large polyp removed during their procedure. Randomization produced one important imbalance in assignment: 25% of the 454 patients in the clipped arm were on an antithrombotic drug (either an anticoagulant or antiplatelet drug) at the time of their endoscopy, compared with 33% of the 464 patients in the control arm.

The study’s primary endpoint was the incidence of “severe” bleeding within 30 days after the procedure. The study defined severe bleeding as an event that required hospitalization, need for repeat endoscopy, need for a blood transfusion, or need for any other major intervention, explained Dr. Pohl, who is also on the staff of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Such events occurred in 3.5% of the patients who underwent clipping and in 7.3% of control patients who received no clipping, a statistically significant difference (P = .01). Among patients with proximal polyps, the bleeding rates were 3.3% among clipped patients and 9.9% among controls, also a statistically significant difference. Among patients with distal polyps the bleeding rates were 4.0% among clipped patients and 1.4% among controls, a difference that was not statistically significant.

Dr. Pohl and his associates ran three other prespecified, secondary analyses that divided the enrolled patients into subgroups. These analyses showed no significant effect on outcome by polyp size when comparing 20-39 mm polyps with polyps 40 mm or larger, treatment with an antithrombotic drug, or method of cauterization. The median time to severe bleeding was 1 day among the controls and 7 days among the clipped patients.

Aside from the difference in rates of delayed bleeding, the two study arms showed no significant differences in the incidence of any other serious postprocedure events. The rates of these nonbleeding events were 1.3% among clipped patients and 2.4% among the controls.

The researchers ran all these analyses based on the intention-to-treat assignment of patients. However, during the study, 9% of patients assigned to the control arm crossed over ended up receiving clips during their procedure after all, a rate that Dr. Pohl called “surprisingly high,” whereas 14% of patients assigned to the clip arm never received clips. A per-protocol analysis that censored patients who did not receive their assigned treatment showed that, among the remaining patients who underwent their assigned treatment, the rate of delayed, severe bleeds was 2.3% among the 390 patients actually treated with clips and 7.2% among the 419 controls who never received clips, a statistically significant difference, he reported.

Dr. Pohl also noted that it was “somewhat surprising” that clipping appeared to result in complete closure in “only” 68% of patients who underwent clipping and that it produced partial closure in an additional 20% of patients, with the remaining patients having mucosal defects that were not considered closed by clipping.

The study was funded by Boston Scientific, the company that markets the hemostatic clip (Resolution 360) tested in the study. Dr. Pohl had no additional disclosures. Dr. Saltzman had no disclosures.

[email protected]

SOURCE: Pohl H et al. Digestive Disease Week, Presentation 886.

WASHINGTON – Using hemostatic clips to close colonic mucosal defects following endoscopic removal of larger polyps cut the rate of delayed, severe bleeding episodes in half in a multicenter, randomized trial with 918 patients.

“The benefit appears limited to proximal polyps,” Heiko Pohl, MD, said at the annual Digestive Disease Week^®. In that prespecified subgroup, which included two-thirds of enrolled patients, placement of hemostatic clips on defects left after removing polyps 20 mm in diameter or larger cut the rate of delayed, severe bleeding by two-thirds, compared with patients with large defects not treated with clips. This result represented a number needed to treat with clips of 15 patients with large proximal polyps to prevent one episode of delayed severe bleeding, said Dr. Pohl, a gastroenterologist at the VA Medical Center in White River Junction, Vt.

Mitchel L. Zoler/MDedge News

Although the results that Dr. Pohl reported came from a trial that originally had been designed to generate data for Food and Drug Administration approval for using the clips to close defects following large polyp removal, the clips received approval for this indication from the agency in 2016 while the study was still in progress.

But Dr. Pohl maintained that the new evidence for efficacy that he reported will provide further impetus for gastroenterologists to use clips when they remove larger polyps in proximal locations. “I think this study will help standardize treatment of mucosal resections and change clip use,” he said in an interview.

“This was a terrific study, and one that needed to be done,” commented John R. Saltzman, MD, professor of medicine at Harvard Medical School and director of endoscopy at Brigham and Women’s Hospital in Boston. But Dr. Saltzman, who spoke from the floor during discussion of Dr. Pohl’s report, added that data on the average number of clips required to close defects were needed to assess the cost-effectiveness of the treatment, data that Dr. Pohl said were available but still being analyzed.

“We have to know how many clips to use and how to close the polyp,” Dr. Saltzman said. Dr. Pohl estimated that roughly four or five clips had been used per defect, but he cautioned that this estimate was preliminary pending his complete analysis of the data.

The CLIP (Clip Closure After Endoscopic Resection of Large Polyps) study enrolled patients with at least one nonpedunculated colonic polyp that was at least 20 mm in diameter at 16 U.S. centers, as well as one center in Montreal and one in Barcelona. The patients averaged 65 years of age, and 6%-7% of patients had more than one large polyp removed during their procedure. Randomization produced one important imbalance in assignment: 25% of the 454 patients in the clipped arm were on an antithrombotic drug (either an anticoagulant or antiplatelet drug) at the time of their endoscopy, compared with 33% of the 464 patients in the control arm.

The study’s primary endpoint was the incidence of “severe” bleeding within 30 days after the procedure. The study defined severe bleeding as an event that required hospitalization, need for repeat endoscopy, need for a blood transfusion, or need for any other major intervention, explained Dr. Pohl, who is also on the staff of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Such events occurred in 3.5% of the patients who underwent clipping and in 7.3% of control patients who received no clipping, a statistically significant difference (P = .01). Among patients with proximal polyps, the bleeding rates were 3.3% among clipped patients and 9.9% among controls, also a statistically significant difference. Among patients with distal polyps the bleeding rates were 4.0% among clipped patients and 1.4% among controls, a difference that was not statistically significant.

Dr. Pohl and his associates ran three other prespecified, secondary analyses that divided the enrolled patients into subgroups. These analyses showed no significant effect on outcome by polyp size when comparing 20-39 mm polyps with polyps 40 mm or larger, treatment with an antithrombotic drug, or method of cauterization. The median time to severe bleeding was 1 day among the controls and 7 days among the clipped patients.

Aside from the difference in rates of delayed bleeding, the two study arms showed no significant differences in the incidence of any other serious postprocedure events. The rates of these nonbleeding events were 1.3% among clipped patients and 2.4% among the controls.

The researchers ran all these analyses based on the intention-to-treat assignment of patients. However, during the study, 9% of patients assigned to the control arm crossed over ended up receiving clips during their procedure after all, a rate that Dr. Pohl called “surprisingly high,” whereas 14% of patients assigned to the clip arm never received clips. A per-protocol analysis that censored patients who did not receive their assigned treatment showed that, among the remaining patients who underwent their assigned treatment, the rate of delayed, severe bleeds was 2.3% among the 390 patients actually treated with clips and 7.2% among the 419 controls who never received clips, a statistically significant difference, he reported.

Dr. Pohl also noted that it was “somewhat surprising” that clipping appeared to result in complete closure in “only” 68% of patients who underwent clipping and that it produced partial closure in an additional 20% of patients, with the remaining patients having mucosal defects that were not considered closed by clipping.

The study was funded by Boston Scientific, the company that markets the hemostatic clip (Resolution 360) tested in the study. Dr. Pohl had no additional disclosures. Dr. Saltzman had no disclosures.

[email protected]

SOURCE: Pohl H et al. Digestive Disease Week, Presentation 886.

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors > 300 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of April 1, 2017; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Impact of Family History and Decision Support on High-Risk Cancer Screening

There is no standardized system for collecting and updating family health history, using this information to determine a patient’s disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into a program that will produce screening recommendations tailored to the patient’s family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
ID: NCT02247336
Sponsor: VA Office of Research and Development
Location (contact): Durham VAMC, North Carolina (Jamiyla Bolton, Susan B. Armstrong); William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin (Corrine Voils)

Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer

The investigators propose to perform a large, simple, multicenter, randomized, parallel-group trial directly comparing screening colonoscopy with annual fecal immunochemical test screening in average risk individuals. The hypothesis is that colonoscopy will be superior to fecal immunochemical testing in the prevention of colorectal cancer (CRC) mortality measured over 10 years. The primary study endpoint will be CRC mortality within 10 years of enrollment.
ID: NCT01239082
Sponsor: VA Office of Research and Development
Locations: 48 current locations

S0820, Adenoma and Second Primary Prevention Trial (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a 3-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
ID: NCT01349881
Sponsor: Southwest Oncology Group
Location (contact): VA Connecticut Healthcare System-West Haven Campus (Michal Rose); Edward Hines Jr. VA Hospital, Hines, Illinois (Abdul Choudhury); Kansas City VAMC, Missouri (Joaquina Baranda); White River Junction VAMC, Vermont (Nancy Kuemmerle); Eisenhower Army Medical Center, Fort Gordon, Georgia (Andrew Delmas); Tripler Army Medical Center, Honolulu, Hawaii (Jeffrey Berenberg); Brooke Army Medical Center, Fort Sam Houston, Texas (John Renshaw)

Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab

This randomized phase II trial is studying the adverse effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
ID: NCT01079780
Sponsor: Eastern Cooperative Oncology Group
Location (contact): Atlanta VAMC, Decatur, Georgia (Samuel Chan); VA New Jersey Health Care System East Orange Campus (Basil Kasimis)

Cancer Associated Thrombosis and Isoquercetin

This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots) in participants who have pancreas, non-small cell lung cancer or colorectal cancer.
ID: NCT02195232
Sponsor: Dana-Farber Cancer Institute
Location (contact): Washington DC VAMC (Anita Aggarwal); Boston VA Healthcare System, Massachusetts (Kenneth Bauer); White River Junction VAMC, Vermont (Nancy Kuemmerle)

Studying Lymph Nodes in Patients With Stage II Colon Cancer

Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease. This phase I trial is studying lymph nodes in patients with stage II colon cancer.
ID: NCT00949312
Sponsor: John Wayne Cancer Institute
Location: Walter Reed Army Medical Center, Washington, DC

Click here to read the digital edition.

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors > 300 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of April 1, 2017; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Impact of Family History and Decision Support on High-Risk Cancer Screening

There is no standardized system for collecting and updating family health history, using this information to determine a patient’s disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into a program that will produce screening recommendations tailored to the patient’s family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
ID: NCT02247336
Sponsor: VA Office of Research and Development
Location (contact): Durham VAMC, North Carolina (Jamiyla Bolton, Susan B. Armstrong); William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin (Corrine Voils)

Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer

The investigators propose to perform a large, simple, multicenter, randomized, parallel-group trial directly comparing screening colonoscopy with annual fecal immunochemical test screening in average risk individuals. The hypothesis is that colonoscopy will be superior to fecal immunochemical testing in the prevention of colorectal cancer (CRC) mortality measured over 10 years. The primary study endpoint will be CRC mortality within 10 years of enrollment.
ID: NCT01239082
Sponsor: VA Office of Research and Development
Locations: 48 current locations

S0820, Adenoma and Second Primary Prevention Trial (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a 3-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
ID: NCT01349881
Sponsor: Southwest Oncology Group
Location (contact): VA Connecticut Healthcare System-West Haven Campus (Michal Rose); Edward Hines Jr. VA Hospital, Hines, Illinois (Abdul Choudhury); Kansas City VAMC, Missouri (Joaquina Baranda); White River Junction VAMC, Vermont (Nancy Kuemmerle); Eisenhower Army Medical Center, Fort Gordon, Georgia (Andrew Delmas); Tripler Army Medical Center, Honolulu, Hawaii (Jeffrey Berenberg); Brooke Army Medical Center, Fort Sam Houston, Texas (John Renshaw)

Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab

This randomized phase II trial is studying the adverse effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
ID: NCT01079780
Sponsor: Eastern Cooperative Oncology Group
Location (contact): Atlanta VAMC, Decatur, Georgia (Samuel Chan); VA New Jersey Health Care System East Orange Campus (Basil Kasimis)

Cancer Associated Thrombosis and Isoquercetin

This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots) in participants who have pancreas, non-small cell lung cancer or colorectal cancer.
ID: NCT02195232
Sponsor: Dana-Farber Cancer Institute
Location (contact): Washington DC VAMC (Anita Aggarwal); Boston VA Healthcare System, Massachusetts (Kenneth Bauer); White River Junction VAMC, Vermont (Nancy Kuemmerle)

Studying Lymph Nodes in Patients With Stage II Colon Cancer

Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease. This phase I trial is studying lymph nodes in patients with stage II colon cancer.
ID: NCT00949312
Sponsor: John Wayne Cancer Institute
Location: Walter Reed Army Medical Center, Washington, DC

Click here to read the digital edition.

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors > 300 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of April 1, 2017; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Impact of Family History and Decision Support on High-Risk Cancer Screening

There is no standardized system for collecting and updating family health history, using this information to determine a patient’s disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into a program that will produce screening recommendations tailored to the patient’s family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
ID: NCT02247336
Sponsor: VA Office of Research and Development
Location (contact): Durham VAMC, North Carolina (Jamiyla Bolton, Susan B. Armstrong); William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin (Corrine Voils)

Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer

The investigators propose to perform a large, simple, multicenter, randomized, parallel-group trial directly comparing screening colonoscopy with annual fecal immunochemical test screening in average risk individuals. The hypothesis is that colonoscopy will be superior to fecal immunochemical testing in the prevention of colorectal cancer (CRC) mortality measured over 10 years. The primary study endpoint will be CRC mortality within 10 years of enrollment.
ID: NCT01239082
Sponsor: VA Office of Research and Development
Locations: 48 current locations

S0820, Adenoma and Second Primary Prevention Trial (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a 3-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
ID: NCT01349881
Sponsor: Southwest Oncology Group
Location (contact): VA Connecticut Healthcare System-West Haven Campus (Michal Rose); Edward Hines Jr. VA Hospital, Hines, Illinois (Abdul Choudhury); Kansas City VAMC, Missouri (Joaquina Baranda); White River Junction VAMC, Vermont (Nancy Kuemmerle); Eisenhower Army Medical Center, Fort Gordon, Georgia (Andrew Delmas); Tripler Army Medical Center, Honolulu, Hawaii (Jeffrey Berenberg); Brooke Army Medical Center, Fort Sam Houston, Texas (John Renshaw)

Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab

This randomized phase II trial is studying the adverse effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
ID: NCT01079780
Sponsor: Eastern Cooperative Oncology Group
Location (contact): Atlanta VAMC, Decatur, Georgia (Samuel Chan); VA New Jersey Health Care System East Orange Campus (Basil Kasimis)

Cancer Associated Thrombosis and Isoquercetin

This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots) in participants who have pancreas, non-small cell lung cancer or colorectal cancer.
ID: NCT02195232
Sponsor: Dana-Farber Cancer Institute
Location (contact): Washington DC VAMC (Anita Aggarwal); Boston VA Healthcare System, Massachusetts (Kenneth Bauer); White River Junction VAMC, Vermont (Nancy Kuemmerle)

Studying Lymph Nodes in Patients With Stage II Colon Cancer

Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease. This phase I trial is studying lymph nodes in patients with stage II colon cancer.
ID: NCT00949312
Sponsor: John Wayne Cancer Institute
Location: Walter Reed Army Medical Center, Washington, DC

Click here to read the digital edition.

The Food and Drug Administration announced May 7 that it has permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.

The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.

“The device provides an additional, nonsurgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.

Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*

Read the full press release here.

[email protected]

Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.

The Food and Drug Administration announced May 7 that it has permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.

The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.

“The device provides an additional, nonsurgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.

Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*

Read the full press release here.

[email protected]

Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.

The Food and Drug Administration announced May 7 that it has permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.

The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.

“The device provides an additional, nonsurgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.

Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*

Read the full press release here.

[email protected]

Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.

CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.

• DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
• The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
• Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.

He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.

Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

SOURCE: Huges BD. SSO 2018.

CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.

• DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
• The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
• Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.

He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.

Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

SOURCE: Huges BD. SSO 2018.

CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.

• DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
• The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
• Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.

He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.

Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

SOURCE: Huges BD. SSO 2018.

CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”

The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.

The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).

Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.

Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.

The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).

During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.

Dr. Roxburgh and coauthors reported having no financial disclosures.

SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.

CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”

The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.

The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).

Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.

Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.

The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).

During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.

Dr. Roxburgh and coauthors reported having no financial disclosures.

SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.

CHICAGO – Delaying surgery after neoadjuvant therapy for locally advanced rectal cancer for up to 12 weeks does not seem to impact complication rates compared to surgery at 8 weeks or earlier, findings that run counter to results from a major European clinical trial reported in 2016, investigators reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There’s an increasing trend toward delayed surgery beyond eight to 12 weeks after neoadjuvant therapy (NT) for locally advanced rectal cancer (LARC),” said Campbell Roxburgh, FRCS, PhD, of the University of Glasgow in Scotland. “Although we saw an increase in all complications in patients who had surgery beyond 12 weeks, there were no increases in surgical site complications, grade 3-5 complications, or anastomotic leaks. Before 12 weeks we did not observe increases in any type of complication where surgery was performed prior to or after 8 weeks.”

The study involved 798 patients who had received NT for LARC from June 2009 to March 2014 at Memorial Sloan Kettering Cancer Center in New York. The vast majority – 76% (607) – had rectal resection within 16 weeks of completing NT. Among them, 52% (317) had surgery 5-8 weeks after NT, 38% (229) had surgery at 8-12 weeks post-NT, and 10% (61) had surgery 12-16 weeks after completing NT. Those who had surgery beyond 16 weeks mostly had it deferred because they were undergoing nonoperative management in the case of complete clinical response to treatment or had a comorbidity that prevented earlier surgery, Dr. Roxburgh said.

The complication rate was 42.3% among the patients who had surgery up to 16 weeks after NT, Dr. Roxburgh said. The most common complication was surgical site infection (SSI) in 16.6% (101), followed by a grade 3-5 complication in 10.5% (64) and anastomotic leak in 6.4% (39). Overall complication rates among the two groups that had surgery within 12 weeks were not statistically different from the overall complication rate, Dr. Roxburgh said: 42.5% (138) in the 5- to 8-week group; and 36.7% (84) in the 8- to 12-week group. The 12- to16-week group had a complication rate of 56% (34, P = .022).

Dr. Roxburgh noted that the idea of delaying surgery beyond 8 weeks after NT has been a subject of debate, and that these findings run counter to those reported in the GRECCAR-6 trial (J Clin Oncol. 2016;34:3773-80). That study compared groups that had surgery for rectal cancer at 7 and 11 weeks after neoadjuvant radiochemotherapy and found that those in the 11-week group had higher rates of complications.

Dr. Roxburgh also reported on an analysis of the 12- to 16-week subgroup that found the highest complication rates were among those who had low anterior resection (53% vs. 41% in the 5- to 8-week group and 31% in the 8- to 12-week population), and patients who had a poor treatment response (no T-downstaging, 66% vs. 44% and 33%, respectively). Age, pretreatment and posttreatment TNM stages, surgical approach (open or minimally invasive), and year of treatment did not factor in complication rates in the subgroup analysis, Dr. Roxburgh noted.

The univariate regression analysis determined a trend toward increased rates of all complications in the 12- to 16-week group (P = .081). But the multivariate analysis did not find timing of surgery to be an independent risk factor for all complications, Dr. Roxburgh said. “We believe other factors, including tumor location, the type of NT, operative approach, and treatment response, however, were more important on multivariate analysis,” he said. For example, open surgery had an odds ratio of 1.7 (P = .004).

During the discussion, Dr. Roxburgh was asked what would be the optimal timing for resection after NT in LARC. “I would recommend posttreatment assessment with MRI and proctoscopy between 8 to 12 weeks and in the case of residual tumor or incomplete response to treatment, scheduling surgery at that time,” he said.

Dr. Roxburgh and coauthors reported having no financial disclosures.

SOURCE: Roxburgh C, et al. Society of Surgical Oncology Annual Cancer Symposium Abstract No. 3.

Clinicians at Centro Hospitalar do Porto in Portugal reported on the case to highlight risk factors for tumor lysis syndrome (TLS).  After 3 cycles of folinic acid, 5-fluorouracil and oxaliplatin (FOLFOX), the patient developed nausea, mild asthenia, tremors, and hyperkalemia that did not respond to standard measures. The differential diagnosis included dehydration, hypotension, exposure to nephrotoxic drugs, and obstructive uropathy, as well as TLS. The patient was diagnosed with acute kidney injury and TLS.

Tumor lysis syndrome is common after the beginning of antineoplastic treatments. As massive amounts of tumor cells are killed, intracellular electrolytes and metabolites flood into the bloodstream. If the metabolites exceed the renal clearance threshold, serious complications ensue, including cardiac arrhythmias or seizures and death. Mortality rates related to TLS in solid tumors can be as high as 35%, the clinicians say. Acute kidney injury during chemotherapy should raise warning flags about TLS, they add, particularly because prompt diagnosis is crucial for short-term outcomes.

The patient was admitted immediately to the intensive care unit with the main aim of preventing severe cardiac events and reversing crystal nephropathy. Adding targeted therapy might have worsened the TLS, so the clinicians opted for high-risk prophylaxis. They advise having rasburicase readily available for treating TLS to degrade urate crystals and reverse nephropathy, reducing the need for renal replacement therapy. However, the clinicians caution that rasburicase and allopurinol (another option) are not free of toxicity.

After a reevaluation computer tomography scan showed that the hepatomegaly was reduced with smaller liver metastases, the clinicians switched the patient to low-risk prophylaxis. The TLS did not recur.

Chemosensitivity, which raises the risk of TLS, is low in colon cancer, the clinicians say. High tumor burden and high proliferation rates seem to be better predictors for TLS.

Source:
Gouveia HS, Lopes SO, Faria AL. BMJ Case Rep. 2018;2018. pii: bcr-2017-223474.
doi: 10.1136/bcr-2017-223474.

Clinicians at Centro Hospitalar do Porto in Portugal reported on the case to highlight risk factors for tumor lysis syndrome (TLS).  After 3 cycles of folinic acid, 5-fluorouracil and oxaliplatin (FOLFOX), the patient developed nausea, mild asthenia, tremors, and hyperkalemia that did not respond to standard measures. The differential diagnosis included dehydration, hypotension, exposure to nephrotoxic drugs, and obstructive uropathy, as well as TLS. The patient was diagnosed with acute kidney injury and TLS.

Tumor lysis syndrome is common after the beginning of antineoplastic treatments. As massive amounts of tumor cells are killed, intracellular electrolytes and metabolites flood into the bloodstream. If the metabolites exceed the renal clearance threshold, serious complications ensue, including cardiac arrhythmias or seizures and death. Mortality rates related to TLS in solid tumors can be as high as 35%, the clinicians say. Acute kidney injury during chemotherapy should raise warning flags about TLS, they add, particularly because prompt diagnosis is crucial for short-term outcomes.

The patient was admitted immediately to the intensive care unit with the main aim of preventing severe cardiac events and reversing crystal nephropathy. Adding targeted therapy might have worsened the TLS, so the clinicians opted for high-risk prophylaxis. They advise having rasburicase readily available for treating TLS to degrade urate crystals and reverse nephropathy, reducing the need for renal replacement therapy. However, the clinicians caution that rasburicase and allopurinol (another option) are not free of toxicity.

After a reevaluation computer tomography scan showed that the hepatomegaly was reduced with smaller liver metastases, the clinicians switched the patient to low-risk prophylaxis. The TLS did not recur.

Chemosensitivity, which raises the risk of TLS, is low in colon cancer, the clinicians say. High tumor burden and high proliferation rates seem to be better predictors for TLS.

Source:
Gouveia HS, Lopes SO, Faria AL. BMJ Case Rep. 2018;2018. pii: bcr-2017-223474.
doi: 10.1136/bcr-2017-223474.

Clinicians at Centro Hospitalar do Porto in Portugal reported on the case to highlight risk factors for tumor lysis syndrome (TLS).  After 3 cycles of folinic acid, 5-fluorouracil and oxaliplatin (FOLFOX), the patient developed nausea, mild asthenia, tremors, and hyperkalemia that did not respond to standard measures. The differential diagnosis included dehydration, hypotension, exposure to nephrotoxic drugs, and obstructive uropathy, as well as TLS. The patient was diagnosed with acute kidney injury and TLS.

Tumor lysis syndrome is common after the beginning of antineoplastic treatments. As massive amounts of tumor cells are killed, intracellular electrolytes and metabolites flood into the bloodstream. If the metabolites exceed the renal clearance threshold, serious complications ensue, including cardiac arrhythmias or seizures and death. Mortality rates related to TLS in solid tumors can be as high as 35%, the clinicians say. Acute kidney injury during chemotherapy should raise warning flags about TLS, they add, particularly because prompt diagnosis is crucial for short-term outcomes.

The patient was admitted immediately to the intensive care unit with the main aim of preventing severe cardiac events and reversing crystal nephropathy. Adding targeted therapy might have worsened the TLS, so the clinicians opted for high-risk prophylaxis. They advise having rasburicase readily available for treating TLS to degrade urate crystals and reverse nephropathy, reducing the need for renal replacement therapy. However, the clinicians caution that rasburicase and allopurinol (another option) are not free of toxicity.

After a reevaluation computer tomography scan showed that the hepatomegaly was reduced with smaller liver metastases, the clinicians switched the patient to low-risk prophylaxis. The TLS did not recur.

Chemosensitivity, which raises the risk of TLS, is low in colon cancer, the clinicians say. High tumor burden and high proliferation rates seem to be better predictors for TLS.

Source:
Gouveia HS, Lopes SO, Faria AL. BMJ Case Rep. 2018;2018. pii: bcr-2017-223474.
doi: 10.1136/bcr-2017-223474.

CHICAGO – Clinical guidelines recommend 12 lymph nodes or more are needed to achieve adequate sampling in colon cancer, but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.

Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.

“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”

Dr. Dehal and his coauthors reported having no financial disclosures.

SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.

*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type

CHICAGO – Clinical guidelines recommend 12 lymph nodes or more are needed to achieve adequate sampling in colon cancer, but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.

Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.

“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”

Dr. Dehal and his coauthors reported having no financial disclosures.

SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.

*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type

CHICAGO – Clinical guidelines recommend 12 lymph nodes or more are needed to achieve adequate sampling in colon cancer, but those guidelines may need to be revised to take into account which side the cancer is on to accurately stage a subset of patients with colon cancer, according to results of a prospective, multicenter clinical trial presented at the Society of Surgical Oncology Annual Cancer Symposium.

Ahmed Dehal, MD, of John Wayne Canter Institute in Santa Monica, Calif., presented results of the trial that compared nodal staging in right-sided vs. left-sided colon cancer in two cohorts with T3N0 colon cancer who had at least one lymph node examined: a group of 370 patients from the randomized, multicenter prospective trial; and a sampling of 153,945 patients in the National Cancer Database (NCDB). The latter was used to validate findings in the trial group.

“Current guidelines regarding the minimum number of nodes needed to accurately stage patients with node-negative T3 colon cancer may need to be reevaluated given that the decision to give those patients chemotherapy is largely based on the nodal status,” he said. “More studies are needed to improve our understanding of the impact of sidedness on nodal staging in the colon cancer.”

Dr. Dehal and his coauthors reported having no financial disclosures.

SOURCE: Dehal A et al. Society of Surgical Oncology Annual Cancer Symposium. Abstract #23: Accuracy of nodal staging is influenced by sidedness in colon cancer: Results of a multicenter prospective trial.

*CORRECTION, 4/4/2018; a previous version of this story misidentified the cancer type

BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.

We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.

[email protected]

BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.

We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.

[email protected]

BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.

We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.

[email protected]