Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.

Key clinical point: Real-world analysis confirms the safety and efficacy of trifluridine/tipiracil observed in phase 3 studies in metastatic colorectal cancer (mCRC).

Major finding: The median overall survival and progression-free survival was 7.6 (95% confidence interval [CI], 6.5-8.6) months and 3.3 (95% CI, 3.03-3.57) months, respectively. The objective response rate and disease control rate were 2.4% and 24.0%, respectively. The most frequent grade 3 toxicities included neutropenia (37%), fatigue (10%), anemia (9%), and febrile neutropenia (5%). Overall, 27% of patients required dose reduction mainly because of hematological toxicities (60%).

Study details: This was a retrospective analysis of 236 patients with chemotherapy refractive mCRC who received at least 1 dose of trifluridine/tipiracil as third-line treatment.

Disclosures: The study did not declare any source of funding. Some of the authors including the lead author declared receiving research funding, travel and accommodation expenses, honoraria, and/or lecture fees from and/or served in consulting or advisory roles for various sources.

Source: Stavraka C et al. Clin Colorectal Cancer. 2021 Sep 26. doi: 10.1016/j.clcc.2021.09.009.

Key clinical point: Real-world analysis confirms the safety and efficacy of trifluridine/tipiracil observed in phase 3 studies in metastatic colorectal cancer (mCRC).

Major finding: The median overall survival and progression-free survival was 7.6 (95% confidence interval [CI], 6.5-8.6) months and 3.3 (95% CI, 3.03-3.57) months, respectively. The objective response rate and disease control rate were 2.4% and 24.0%, respectively. The most frequent grade 3 toxicities included neutropenia (37%), fatigue (10%), anemia (9%), and febrile neutropenia (5%). Overall, 27% of patients required dose reduction mainly because of hematological toxicities (60%).

Study details: This was a retrospective analysis of 236 patients with chemotherapy refractive mCRC who received at least 1 dose of trifluridine/tipiracil as third-line treatment.

Disclosures: The study did not declare any source of funding. Some of the authors including the lead author declared receiving research funding, travel and accommodation expenses, honoraria, and/or lecture fees from and/or served in consulting or advisory roles for various sources.

Source: Stavraka C et al. Clin Colorectal Cancer. 2021 Sep 26. doi: 10.1016/j.clcc.2021.09.009.

Key clinical point: Real-world analysis confirms the safety and efficacy of trifluridine/tipiracil observed in phase 3 studies in metastatic colorectal cancer (mCRC).

Major finding: The median overall survival and progression-free survival was 7.6 (95% confidence interval [CI], 6.5-8.6) months and 3.3 (95% CI, 3.03-3.57) months, respectively. The objective response rate and disease control rate were 2.4% and 24.0%, respectively. The most frequent grade 3 toxicities included neutropenia (37%), fatigue (10%), anemia (9%), and febrile neutropenia (5%). Overall, 27% of patients required dose reduction mainly because of hematological toxicities (60%).

Study details: This was a retrospective analysis of 236 patients with chemotherapy refractive mCRC who received at least 1 dose of trifluridine/tipiracil as third-line treatment.

Disclosures: The study did not declare any source of funding. Some of the authors including the lead author declared receiving research funding, travel and accommodation expenses, honoraria, and/or lecture fees from and/or served in consulting or advisory roles for various sources.

Source: Stavraka C et al. Clin Colorectal Cancer. 2021 Sep 26. doi: 10.1016/j.clcc.2021.09.009.

Key clinical point: Adavosertib vs active monitoring (AM) following induction chemotherapy showed a significant progression-free survival (PFS) advantage along with a favorable safety profile in patients with RAS/TP53-mutant metastatic colorectal cancer (mCRC).

Major finding: Adavosertib showed significant PFS advantage over AM (3.61 months vs 1.87 months; adjusted hazard ratio, 0.35; P = .0022). The frequency of diarrhea (61% vs 28%), fatigue (75% vs 56%), nausea (68% vs 32%), and vomiting (41% vs 4%) were higher in adavosertib than AM arms, with majority being low grade.

Study details: Findings are from FOCUS4-C, a phase 2 trial including patients with RAS/TP53-mutant mCRC who had stable disease or response at the end of 16-week induction chemotherapy and were further randomly assigned to AM (n=25) or adavosertib (n=44).

Disclosures: FOCUS4-C was cofunded by the MRC/NIHR Efficacy and Mechanism Evaluation program and CRUK. AstraZeneca provided drug supply and distribution of adavosertib and an educational grant. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including AstraZeneca.

Source: Seligmann JF et al. J Clin Oncol. 2021 Sep 18. doi: 10.1200/JCO.21. 01435.

Key clinical point: Adavosertib vs active monitoring (AM) following induction chemotherapy showed a significant progression-free survival (PFS) advantage along with a favorable safety profile in patients with RAS/TP53-mutant metastatic colorectal cancer (mCRC).

Major finding: Adavosertib showed significant PFS advantage over AM (3.61 months vs 1.87 months; adjusted hazard ratio, 0.35; P = .0022). The frequency of diarrhea (61% vs 28%), fatigue (75% vs 56%), nausea (68% vs 32%), and vomiting (41% vs 4%) were higher in adavosertib than AM arms, with majority being low grade.

Study details: Findings are from FOCUS4-C, a phase 2 trial including patients with RAS/TP53-mutant mCRC who had stable disease or response at the end of 16-week induction chemotherapy and were further randomly assigned to AM (n=25) or adavosertib (n=44).

Disclosures: FOCUS4-C was cofunded by the MRC/NIHR Efficacy and Mechanism Evaluation program and CRUK. AstraZeneca provided drug supply and distribution of adavosertib and an educational grant. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including AstraZeneca.

Source: Seligmann JF et al. J Clin Oncol. 2021 Sep 18. doi: 10.1200/JCO.21. 01435.

Key clinical point: Adavosertib vs active monitoring (AM) following induction chemotherapy showed a significant progression-free survival (PFS) advantage along with a favorable safety profile in patients with RAS/TP53-mutant metastatic colorectal cancer (mCRC).

Major finding: Adavosertib showed significant PFS advantage over AM (3.61 months vs 1.87 months; adjusted hazard ratio, 0.35; P = .0022). The frequency of diarrhea (61% vs 28%), fatigue (75% vs 56%), nausea (68% vs 32%), and vomiting (41% vs 4%) were higher in adavosertib than AM arms, with majority being low grade.

Study details: Findings are from FOCUS4-C, a phase 2 trial including patients with RAS/TP53-mutant mCRC who had stable disease or response at the end of 16-week induction chemotherapy and were further randomly assigned to AM (n=25) or adavosertib (n=44).

Disclosures: FOCUS4-C was cofunded by the MRC/NIHR Efficacy and Mechanism Evaluation program and CRUK. AstraZeneca provided drug supply and distribution of adavosertib and an educational grant. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including AstraZeneca.

Source: Seligmann JF et al. J Clin Oncol. 2021 Sep 18. doi: 10.1200/JCO.21. 01435.

Key clinical point: Meta-analysis confirms the detrimental effect of KRAS and BRAF mutations on disease-free survival (DFS) and overall survival (OS) in patients with stage II/III colon cancer, with the effect being enhanced by adjustment for microsatellite instability (MSI).

Major finding: KRAS mutations significantly deteriorated both DFS (pooled hazard ratio [pHR], 1.36; P less than .001) and OS (pHR, 1.27; P = .03), whereas BRAF mutations significantly deteriorated only OS (pHR, 1.49; P < .001), but not DFS. Adjustment for MSI enhanced the effect of KRAS (pHR_DFS, 1.43; P = .001; pHR_OS, 1.33; P = .03) and BRAF (pHR_DFS, 1.59; P = .001; pHR_OS, 1.67; P less than .001) mutations.

Study details: This was a meta-analysis of 9 phase 3 adjuvant trials including 10,893 patients with stage II/III colon cancer.

Disclosures: No specific funding was declared. Some of the authors including the lead author declared receiving research funding and personal fees from and/or consulting or advisory role for various sources.

Source: Formica V et al. J Natl Cancer Inst. 2021 Sep 20. doi: 10.1093/jnci/djab190.

Key clinical point: Meta-analysis confirms the detrimental effect of KRAS and BRAF mutations on disease-free survival (DFS) and overall survival (OS) in patients with stage II/III colon cancer, with the effect being enhanced by adjustment for microsatellite instability (MSI).

Major finding: KRAS mutations significantly deteriorated both DFS (pooled hazard ratio [pHR], 1.36; P less than .001) and OS (pHR, 1.27; P = .03), whereas BRAF mutations significantly deteriorated only OS (pHR, 1.49; P < .001), but not DFS. Adjustment for MSI enhanced the effect of KRAS (pHR_DFS, 1.43; P = .001; pHR_OS, 1.33; P = .03) and BRAF (pHR_DFS, 1.59; P = .001; pHR_OS, 1.67; P less than .001) mutations.

Study details: This was a meta-analysis of 9 phase 3 adjuvant trials including 10,893 patients with stage II/III colon cancer.

Disclosures: No specific funding was declared. Some of the authors including the lead author declared receiving research funding and personal fees from and/or consulting or advisory role for various sources.

Source: Formica V et al. J Natl Cancer Inst. 2021 Sep 20. doi: 10.1093/jnci/djab190.

Key clinical point: Meta-analysis confirms the detrimental effect of KRAS and BRAF mutations on disease-free survival (DFS) and overall survival (OS) in patients with stage II/III colon cancer, with the effect being enhanced by adjustment for microsatellite instability (MSI).

Major finding: KRAS mutations significantly deteriorated both DFS (pooled hazard ratio [pHR], 1.36; P less than .001) and OS (pHR, 1.27; P = .03), whereas BRAF mutations significantly deteriorated only OS (pHR, 1.49; P < .001), but not DFS. Adjustment for MSI enhanced the effect of KRAS (pHR_DFS, 1.43; P = .001; pHR_OS, 1.33; P = .03) and BRAF (pHR_DFS, 1.59; P = .001; pHR_OS, 1.67; P less than .001) mutations.

Study details: This was a meta-analysis of 9 phase 3 adjuvant trials including 10,893 patients with stage II/III colon cancer.

Disclosures: No specific funding was declared. Some of the authors including the lead author declared receiving research funding and personal fees from and/or consulting or advisory role for various sources.

Source: Formica V et al. J Natl Cancer Inst. 2021 Sep 20. doi: 10.1093/jnci/djab190.

Key clinical point: Addition of panitumumab (Pmab) to fluorouracil/folinic acid (FU/FA) maintenance therapy significantly prolonged progression-free survival (PFS) compared with FU/FA alone in patients with RAS wild-type metastatic colorectal cancer (mCRC).

Major finding: The trial achieved its primary endpoint with a significant improvement in PFS with the addition of Pmab to FU/FA vs. only FU/FA maintenance therapy (8.8 months vs. 5.7 months; hazard ratio [HR], 0.72; P = .014). The most frequent grade 3 or more adverse event during maintenance in the Pmab arm was acneiform rash (7.2%).

Study details: PANAMA, a phase 2 trial included 377 patients with RAS wild-type mCRC who received induction therapy with 6 cycles of FOLFOX+Pmab. Patients with stable disease, partial or complete remission after induction, were randomly assigned to FU/FA+Pmab (n=125) or only FU/FA (n=123) maintenance therapy.

Disclosures: This trial was funded by AIO Studien gGmbH, Berlin, Germany, and Amgen. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including Amgen.

Source: Modest DP et al. J Clin Oncol. 2021 Sep 17. doi: 10.1200/JCO.21.01332.

Key clinical point: Addition of panitumumab (Pmab) to fluorouracil/folinic acid (FU/FA) maintenance therapy significantly prolonged progression-free survival (PFS) compared with FU/FA alone in patients with RAS wild-type metastatic colorectal cancer (mCRC).

Major finding: The trial achieved its primary endpoint with a significant improvement in PFS with the addition of Pmab to FU/FA vs. only FU/FA maintenance therapy (8.8 months vs. 5.7 months; hazard ratio [HR], 0.72; P = .014). The most frequent grade 3 or more adverse event during maintenance in the Pmab arm was acneiform rash (7.2%).

Study details: PANAMA, a phase 2 trial included 377 patients with RAS wild-type mCRC who received induction therapy with 6 cycles of FOLFOX+Pmab. Patients with stable disease, partial or complete remission after induction, were randomly assigned to FU/FA+Pmab (n=125) or only FU/FA (n=123) maintenance therapy.

Disclosures: This trial was funded by AIO Studien gGmbH, Berlin, Germany, and Amgen. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including Amgen.

Source: Modest DP et al. J Clin Oncol. 2021 Sep 17. doi: 10.1200/JCO.21.01332.

Key clinical point: Addition of panitumumab (Pmab) to fluorouracil/folinic acid (FU/FA) maintenance therapy significantly prolonged progression-free survival (PFS) compared with FU/FA alone in patients with RAS wild-type metastatic colorectal cancer (mCRC).

Major finding: The trial achieved its primary endpoint with a significant improvement in PFS with the addition of Pmab to FU/FA vs. only FU/FA maintenance therapy (8.8 months vs. 5.7 months; hazard ratio [HR], 0.72; P = .014). The most frequent grade 3 or more adverse event during maintenance in the Pmab arm was acneiform rash (7.2%).

Study details: PANAMA, a phase 2 trial included 377 patients with RAS wild-type mCRC who received induction therapy with 6 cycles of FOLFOX+Pmab. Patients with stable disease, partial or complete remission after induction, were randomly assigned to FU/FA+Pmab (n=125) or only FU/FA (n=123) maintenance therapy.

Disclosures: This trial was funded by AIO Studien gGmbH, Berlin, Germany, and Amgen. The authors declared receiving honoraria, research funding, travel and accommodation expenses, and/or consulting/advisory roles from various sources including Amgen.

Source: Modest DP et al. J Clin Oncol. 2021 Sep 17. doi: 10.1200/JCO.21.01332.

Key clinical point: Survival was not significantly different in patients with metastatic colorectal cancer (mCRC) younger than 50 years vs. those aged 50 years or older.

Major finding: The median overall survival (adjusted hazard ratio [aHR], 0.98; P = .78) and progression-free survival (aHR, 1.02; P = .67) were not significantly different in younger- vs. older-onset patients with mCRC.

Study details: This study included 2,326 patients with mCRC from CALGB/SWOG 80405 phase 3 trial, of which 514 patients younger than 50 years at study entry were included in the younger CRC cohort.

Disclosures: The study was funded by the National Cancer Institute of the National Institutes of Health and in part by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Some of the authors reported receiving research funding/honoraria from and/or consulting/advising for various sources.

Source: Lipsyc-Sharf M et al. J Natl Cancer Inst. 2021 Oct 12. doi: 10.1093/jnci/djab200.

Key clinical point: Survival was not significantly different in patients with metastatic colorectal cancer (mCRC) younger than 50 years vs. those aged 50 years or older.

Major finding: The median overall survival (adjusted hazard ratio [aHR], 0.98; P = .78) and progression-free survival (aHR, 1.02; P = .67) were not significantly different in younger- vs. older-onset patients with mCRC.

Study details: This study included 2,326 patients with mCRC from CALGB/SWOG 80405 phase 3 trial, of which 514 patients younger than 50 years at study entry were included in the younger CRC cohort.

Disclosures: The study was funded by the National Cancer Institute of the National Institutes of Health and in part by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Some of the authors reported receiving research funding/honoraria from and/or consulting/advising for various sources.

Source: Lipsyc-Sharf M et al. J Natl Cancer Inst. 2021 Oct 12. doi: 10.1093/jnci/djab200.

Key clinical point: Survival was not significantly different in patients with metastatic colorectal cancer (mCRC) younger than 50 years vs. those aged 50 years or older.

Major finding: The median overall survival (adjusted hazard ratio [aHR], 0.98; P = .78) and progression-free survival (aHR, 1.02; P = .67) were not significantly different in younger- vs. older-onset patients with mCRC.

Study details: This study included 2,326 patients with mCRC from CALGB/SWOG 80405 phase 3 trial, of which 514 patients younger than 50 years at study entry were included in the younger CRC cohort.

Disclosures: The study was funded by the National Cancer Institute of the National Institutes of Health and in part by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Some of the authors reported receiving research funding/honoraria from and/or consulting/advising for various sources.

Source: Lipsyc-Sharf M et al. J Natl Cancer Inst. 2021 Oct 12. doi: 10.1093/jnci/djab200.

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

Key clinical point: Delaying surgery after completing neoadjuvant chemoradiotherapy (CRT) could be a risk factor for worse outcomes in patients with locally advanced rectal cancer with poor or no pathological response to preoperative CRT.

Major finding: A longer vs. shorter waiting period between surgery and end of CRT was associated with worse overall survival (5 years: 67.6% vs 80.3%; 10 years: 40.1% vs 57.8%; P < .001) and disease-free survival (5 years: 59.6% vs 72.0%; 10 years: 36.2% vs 53.9%; P < .001).

Study details: Findings are from a retrospective analysis of 1,064 patients who underwent CRT and surgery for locally advanced rectal cancer and showed partial or no pathological response to neoadjuvant CRT. Wait time between CRT completion and colorectal surgery categorized patients into shorter (8 weeks or less; n=579) or longer (greater than 8 weeks; n=485) interval groups.

Disclosures: The study did not declare any source of funding. No conflict of interests was reported.

Source: Deidda S et al. JAMA Surg. 2021 Sep 29. doi: 10.1001/jamasurg.2021.4566.

Key clinical point: Delaying surgery after completing neoadjuvant chemoradiotherapy (CRT) could be a risk factor for worse outcomes in patients with locally advanced rectal cancer with poor or no pathological response to preoperative CRT.

Major finding: A longer vs. shorter waiting period between surgery and end of CRT was associated with worse overall survival (5 years: 67.6% vs 80.3%; 10 years: 40.1% vs 57.8%; P < .001) and disease-free survival (5 years: 59.6% vs 72.0%; 10 years: 36.2% vs 53.9%; P < .001).

Study details: Findings are from a retrospective analysis of 1,064 patients who underwent CRT and surgery for locally advanced rectal cancer and showed partial or no pathological response to neoadjuvant CRT. Wait time between CRT completion and colorectal surgery categorized patients into shorter (8 weeks or less; n=579) or longer (greater than 8 weeks; n=485) interval groups.

Disclosures: The study did not declare any source of funding. No conflict of interests was reported.

Source: Deidda S et al. JAMA Surg. 2021 Sep 29. doi: 10.1001/jamasurg.2021.4566.

Key clinical point: Delaying surgery after completing neoadjuvant chemoradiotherapy (CRT) could be a risk factor for worse outcomes in patients with locally advanced rectal cancer with poor or no pathological response to preoperative CRT.

Major finding: A longer vs. shorter waiting period between surgery and end of CRT was associated with worse overall survival (5 years: 67.6% vs 80.3%; 10 years: 40.1% vs 57.8%; P < .001) and disease-free survival (5 years: 59.6% vs 72.0%; 10 years: 36.2% vs 53.9%; P < .001).

Study details: Findings are from a retrospective analysis of 1,064 patients who underwent CRT and surgery for locally advanced rectal cancer and showed partial or no pathological response to neoadjuvant CRT. Wait time between CRT completion and colorectal surgery categorized patients into shorter (8 weeks or less; n=579) or longer (greater than 8 weeks; n=485) interval groups.

Disclosures: The study did not declare any source of funding. No conflict of interests was reported.

Source: Deidda S et al. JAMA Surg. 2021 Sep 29. doi: 10.1001/jamasurg.2021.4566.

Key clinical point: Primary tumor resection (PTR) of asymptomatic tumor followed by systemic therapy is associated with a significantly higher 60-day mortality than systemic therapy alone in patients with nonresectable metastatic colorectal cancer (mCRC).

Major finding: Deaths within 60 days of randomization were significantly higher in the PTR vs systemic therapy alone (11% vs 3%; P = .03) arm with elevated levels of lactate dehydrogenase (P = .046), neutrophils (P = .04), aspartate aminotransferase (P < .001), and alanine aminotransferase (P = .002) being associated with higher 60-day mortality in the PTR arm.

Study details: CAIRO4 is a randomized phase 3 trial including 198 patients with nonresectable mCRC and asymptomatic primary tumor randomly assigned to systemic therapy alone or PTR followed by systemic therapy with palliative intent.

Disclosures: The study was funded by Dutch Cancer Society and Hoffmann-La Roche. Dr. DEW van der Kruijssen, Dr. GR Vink, Dr. JHW de Wilt, and Dr. M Koopman reported receiving grants and/or nonfinancial support from various sources including Hoffmann-La Roche Ltd.

Source: van der Kruijssen DEW et al. JAMA Surg. 2021 Oct 6. doi: 10.1001/jamasurg.2021.4992.

Key clinical point: Primary tumor resection (PTR) of asymptomatic tumor followed by systemic therapy is associated with a significantly higher 60-day mortality than systemic therapy alone in patients with nonresectable metastatic colorectal cancer (mCRC).

Major finding: Deaths within 60 days of randomization were significantly higher in the PTR vs systemic therapy alone (11% vs 3%; P = .03) arm with elevated levels of lactate dehydrogenase (P = .046), neutrophils (P = .04), aspartate aminotransferase (P < .001), and alanine aminotransferase (P = .002) being associated with higher 60-day mortality in the PTR arm.

Study details: CAIRO4 is a randomized phase 3 trial including 198 patients with nonresectable mCRC and asymptomatic primary tumor randomly assigned to systemic therapy alone or PTR followed by systemic therapy with palliative intent.

Disclosures: The study was funded by Dutch Cancer Society and Hoffmann-La Roche. Dr. DEW van der Kruijssen, Dr. GR Vink, Dr. JHW de Wilt, and Dr. M Koopman reported receiving grants and/or nonfinancial support from various sources including Hoffmann-La Roche Ltd.

Source: van der Kruijssen DEW et al. JAMA Surg. 2021 Oct 6. doi: 10.1001/jamasurg.2021.4992.

Key clinical point: Primary tumor resection (PTR) of asymptomatic tumor followed by systemic therapy is associated with a significantly higher 60-day mortality than systemic therapy alone in patients with nonresectable metastatic colorectal cancer (mCRC).

Major finding: Deaths within 60 days of randomization were significantly higher in the PTR vs systemic therapy alone (11% vs 3%; P = .03) arm with elevated levels of lactate dehydrogenase (P = .046), neutrophils (P = .04), aspartate aminotransferase (P < .001), and alanine aminotransferase (P = .002) being associated with higher 60-day mortality in the PTR arm.

Study details: CAIRO4 is a randomized phase 3 trial including 198 patients with nonresectable mCRC and asymptomatic primary tumor randomly assigned to systemic therapy alone or PTR followed by systemic therapy with palliative intent.

Disclosures: The study was funded by Dutch Cancer Society and Hoffmann-La Roche. Dr. DEW van der Kruijssen, Dr. GR Vink, Dr. JHW de Wilt, and Dr. M Koopman reported receiving grants and/or nonfinancial support from various sources including Hoffmann-La Roche Ltd.

Source: van der Kruijssen DEW et al. JAMA Surg. 2021 Oct 6. doi: 10.1001/jamasurg.2021.4992.