American Society for Radiation Oncology (ASTRO): Chicago Multidisciplinary Symposium in Thoracic Oncology

An experimental first-line chemotherapy regimen that included pemetrexed did not improve overall survival compared with standard paclitaxel-based treatment in a phase III randomized, open-label study of more than 900 patients with late-stage lung cancer.

The experimental regimen did improve progression-free survival, a secondary end point of the study called POINTBREAK by Eli Lilly.

Courtesy ASTRO

"The fact that there was no improvement in survival with the experimental regimen was disappointing, but these findings are important as we continue to navigate ways to improve survival for this devastating disease," lead author Dr. Jyoti D. Patel said during a press briefing at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Funded by Lilly, the phase III study compared an experimental regimen of pemetrexed (Alimta) plus carboplatin plus bevacizumab (Avastin) followed by maintenance pemetrexed plus bevacizumab (the Pem arm) with a Food and Drug Administration–approved regimen of paclitaxel plus carboplatin plus bevacizumab followed by maintenance bevacizumab (the Pac Arm) in previously untreated patients with stage IIIB or IV nonsquamous non–small cell lung cancer (NS-NSCLC).

A total of 939 such patients who had Eastern Oncology Cooperative Group performance status of 0-1 were randomized. Patients in the experimental arm received pemetrexed (500 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg) along with folic acid, vitamin B₁₂ and dexamethasone supplementation. The control group received paclitaxel (200 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg), and dexamethasone, diphenhydramine, and cimetidine or ranitidine premedications.

Both regimens were given every 3 weeks for up to four cycles. Patients who continued without progressive disease received maintenance pemetrexed plus bevacizumab (Pem Arm) or maintenance bevacizumab (Pac Arm).

The overall patient population had a median age of 64.7 years, was 53.2% male, and 85.7% white. Nearly all, 90.0%, had stage IV NSCLC, and 79.2% had adenocarcinoma. Only 11.6% had never smoked.

Median overall survival – the primary end point – was 12.6 months in the experimental group (Pem arm) and 13.4 months for the control group (Pac arm), a nonsignificant difference (hazard ratio, 1.00; P = .949. The 1-year survival rates were 52.7% and 54.1%, respectively; the 2-year rates were 24.4% and 21.2%, respectively.

Median progression-free survival was significantly longer for the Pem arm: 6.0 versus 5.6 months (HR, 0.83; P = .012. The overall response rates were 34.1% with pemetrexed and 33.0% with paclitaxel; the disease control rates were 65.9% and 69.8%, respectively, Dr. Patel reported.

The pemetrexed arm has significantly more study drug-related grade 3/4 anemia (14.5% vs. 2.7%), thrombocytopenia (23.3% vs. 5.6%) and fatigue (10.9% vs. 5.0%). The paclitaxel arm had significantly more grade 3/4 neutropenia (40.6% vs. 25.8%), febrile neutropenia (4.1% vs. 1.4%), sensory neuropathy (4.1% vs. 0) and complete (grade 2) alopecia (21.4 % vs. 1.1%). These event rates are similar to those seen in previous trials, she noted.

Hemorrhage – either gastrointestinal or pulmonary and thromboembolic events were infrequent and similar between arms. There were very few grade 5 events, she said.

Study drug-related discontinuations due to severe adverse events (2.7% vs. 3.6%), adverse events (10.4% vs. 9.0%), and study drug-related deaths due to adverse events (1.8% vs. 2.3%) were similar between the two groups (Pem arm vs. Pac arm, respectively).

"It is important to note that both regimens demonstrated tolerability, although their toxicities differed. These differences can be important for our patients," said Dr. Patel of the department of medicine-hematology/oncology at Northwestern University, Chicago.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago

Dr. Patel received a research grant from Eli Lilly for this study. Several of her coauthors had ties to Lilly and other companies including Genentech, Pfizer, and GlaxoSmithKline.

An experimental first-line chemotherapy regimen that included pemetrexed did not improve overall survival compared with standard paclitaxel-based treatment in a phase III randomized, open-label study of more than 900 patients with late-stage lung cancer.

The experimental regimen did improve progression-free survival, a secondary end point of the study called POINTBREAK by Eli Lilly.

Courtesy ASTRO

"The fact that there was no improvement in survival with the experimental regimen was disappointing, but these findings are important as we continue to navigate ways to improve survival for this devastating disease," lead author Dr. Jyoti D. Patel said during a press briefing at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Funded by Lilly, the phase III study compared an experimental regimen of pemetrexed (Alimta) plus carboplatin plus bevacizumab (Avastin) followed by maintenance pemetrexed plus bevacizumab (the Pem arm) with a Food and Drug Administration–approved regimen of paclitaxel plus carboplatin plus bevacizumab followed by maintenance bevacizumab (the Pac Arm) in previously untreated patients with stage IIIB or IV nonsquamous non–small cell lung cancer (NS-NSCLC).

A total of 939 such patients who had Eastern Oncology Cooperative Group performance status of 0-1 were randomized. Patients in the experimental arm received pemetrexed (500 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg) along with folic acid, vitamin B₁₂ and dexamethasone supplementation. The control group received paclitaxel (200 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg), and dexamethasone, diphenhydramine, and cimetidine or ranitidine premedications.

Both regimens were given every 3 weeks for up to four cycles. Patients who continued without progressive disease received maintenance pemetrexed plus bevacizumab (Pem Arm) or maintenance bevacizumab (Pac Arm).

The overall patient population had a median age of 64.7 years, was 53.2% male, and 85.7% white. Nearly all, 90.0%, had stage IV NSCLC, and 79.2% had adenocarcinoma. Only 11.6% had never smoked.

Median overall survival – the primary end point – was 12.6 months in the experimental group (Pem arm) and 13.4 months for the control group (Pac arm), a nonsignificant difference (hazard ratio, 1.00; P = .949. The 1-year survival rates were 52.7% and 54.1%, respectively; the 2-year rates were 24.4% and 21.2%, respectively.

Median progression-free survival was significantly longer for the Pem arm: 6.0 versus 5.6 months (HR, 0.83; P = .012. The overall response rates were 34.1% with pemetrexed and 33.0% with paclitaxel; the disease control rates were 65.9% and 69.8%, respectively, Dr. Patel reported.

The pemetrexed arm has significantly more study drug-related grade 3/4 anemia (14.5% vs. 2.7%), thrombocytopenia (23.3% vs. 5.6%) and fatigue (10.9% vs. 5.0%). The paclitaxel arm had significantly more grade 3/4 neutropenia (40.6% vs. 25.8%), febrile neutropenia (4.1% vs. 1.4%), sensory neuropathy (4.1% vs. 0) and complete (grade 2) alopecia (21.4 % vs. 1.1%). These event rates are similar to those seen in previous trials, she noted.

Hemorrhage – either gastrointestinal or pulmonary and thromboembolic events were infrequent and similar between arms. There were very few grade 5 events, she said.

Study drug-related discontinuations due to severe adverse events (2.7% vs. 3.6%), adverse events (10.4% vs. 9.0%), and study drug-related deaths due to adverse events (1.8% vs. 2.3%) were similar between the two groups (Pem arm vs. Pac arm, respectively).

"It is important to note that both regimens demonstrated tolerability, although their toxicities differed. These differences can be important for our patients," said Dr. Patel of the department of medicine-hematology/oncology at Northwestern University, Chicago.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago

Dr. Patel received a research grant from Eli Lilly for this study. Several of her coauthors had ties to Lilly and other companies including Genentech, Pfizer, and GlaxoSmithKline.

An experimental first-line chemotherapy regimen that included pemetrexed did not improve overall survival compared with standard paclitaxel-based treatment in a phase III randomized, open-label study of more than 900 patients with late-stage lung cancer.

The experimental regimen did improve progression-free survival, a secondary end point of the study called POINTBREAK by Eli Lilly.

Courtesy ASTRO

"The fact that there was no improvement in survival with the experimental regimen was disappointing, but these findings are important as we continue to navigate ways to improve survival for this devastating disease," lead author Dr. Jyoti D. Patel said during a press briefing at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Funded by Lilly, the phase III study compared an experimental regimen of pemetrexed (Alimta) plus carboplatin plus bevacizumab (Avastin) followed by maintenance pemetrexed plus bevacizumab (the Pem arm) with a Food and Drug Administration–approved regimen of paclitaxel plus carboplatin plus bevacizumab followed by maintenance bevacizumab (the Pac Arm) in previously untreated patients with stage IIIB or IV nonsquamous non–small cell lung cancer (NS-NSCLC).

A total of 939 such patients who had Eastern Oncology Cooperative Group performance status of 0-1 were randomized. Patients in the experimental arm received pemetrexed (500 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg) along with folic acid, vitamin B₁₂ and dexamethasone supplementation. The control group received paclitaxel (200 mg/m²) plus carboplatin (AUC = 6) plus bevacizumab (15 mg/kg), and dexamethasone, diphenhydramine, and cimetidine or ranitidine premedications.

Both regimens were given every 3 weeks for up to four cycles. Patients who continued without progressive disease received maintenance pemetrexed plus bevacizumab (Pem Arm) or maintenance bevacizumab (Pac Arm).

The overall patient population had a median age of 64.7 years, was 53.2% male, and 85.7% white. Nearly all, 90.0%, had stage IV NSCLC, and 79.2% had adenocarcinoma. Only 11.6% had never smoked.

Median overall survival – the primary end point – was 12.6 months in the experimental group (Pem arm) and 13.4 months for the control group (Pac arm), a nonsignificant difference (hazard ratio, 1.00; P = .949. The 1-year survival rates were 52.7% and 54.1%, respectively; the 2-year rates were 24.4% and 21.2%, respectively.

Median progression-free survival was significantly longer for the Pem arm: 6.0 versus 5.6 months (HR, 0.83; P = .012. The overall response rates were 34.1% with pemetrexed and 33.0% with paclitaxel; the disease control rates were 65.9% and 69.8%, respectively, Dr. Patel reported.

The pemetrexed arm has significantly more study drug-related grade 3/4 anemia (14.5% vs. 2.7%), thrombocytopenia (23.3% vs. 5.6%) and fatigue (10.9% vs. 5.0%). The paclitaxel arm had significantly more grade 3/4 neutropenia (40.6% vs. 25.8%), febrile neutropenia (4.1% vs. 1.4%), sensory neuropathy (4.1% vs. 0) and complete (grade 2) alopecia (21.4 % vs. 1.1%). These event rates are similar to those seen in previous trials, she noted.

Hemorrhage – either gastrointestinal or pulmonary and thromboembolic events were infrequent and similar between arms. There were very few grade 5 events, she said.

Study drug-related discontinuations due to severe adverse events (2.7% vs. 3.6%), adverse events (10.4% vs. 9.0%), and study drug-related deaths due to adverse events (1.8% vs. 2.3%) were similar between the two groups (Pem arm vs. Pac arm, respectively).

"It is important to note that both regimens demonstrated tolerability, although their toxicities differed. These differences can be important for our patients," said Dr. Patel of the department of medicine-hematology/oncology at Northwestern University, Chicago.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago

Dr. Patel received a research grant from Eli Lilly for this study. Several of her coauthors had ties to Lilly and other companies including Genentech, Pfizer, and GlaxoSmithKline.

Prophylactic cranial irradiation reduced the 5-year rate of brain metastases, but did not improve overall survival in a randomized trial that evaluated 340 patients without disease progression following potentially curative treatment for locally advanced non–small cell lung cancer.

The findings provide important confirmatory information regarding the effectiveness of prophylactic cranial irradiation (PCI) in decreasing the rate of brain failures, Dr. Elizabeth Gore said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Courtesy ASTRO

The trial closed early because of slow patient accrual, however, and did not enroll enough patients to answer the primary question: whether PCI improves overall survival in patients with stage III NSCLC.

"I’d like to emphasize the need for participation in clinical trials. This is particularly important in lung cancer, which is understudied" despite its being the leading cause of cancer death in the United States, said Dr. Gore, professor of radiation oncology at the Medical College of Wisconsin, Milwaukee.

Over a median follow-up of 24.2 months for all patients and 58.6 months for living patients, the 5-year rates of brain metastases were 17.3% for those randomized to receive PCI delivered to 30 Gy in 15 fractions, compared with 26.8% for patients randomized to observation. That difference was statistically significant (P = .009).

However, there were no significant differences in the 5-year rates of survival, (26.1% for PCI and 24.6% for observation), or disease-free survival (18.5% and 14.9%, respectively).

Of the patients with treatment failures, 10% of those receiving PCI and 23% in the observation group experienced failure in the brain initially. Brain metastases (BM) were the only component of first failure in 9.1% and 21.5% of patients with and without PCI, respectively.

On multivariate analysis, PCI was significantly associated with decreased BM, whereas nonsquamous histology was associated with an increased risk of BM. The overall rate of BM in this trial was insufficient for reliable subset analyses by histology, Dr. Gore noted.

"Brain metastasis has a profound impact on patients with lung cancer in terms of quality of life. We need more information to determine which patients are most likely to derive a survival benefit from prophylactic cranial irradiation before this can become a part of standard management," she said.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

Dr. Gore and her associates have no financial disclosures.

Prophylactic cranial irradiation reduced the 5-year rate of brain metastases, but did not improve overall survival in a randomized trial that evaluated 340 patients without disease progression following potentially curative treatment for locally advanced non–small cell lung cancer.

The findings provide important confirmatory information regarding the effectiveness of prophylactic cranial irradiation (PCI) in decreasing the rate of brain failures, Dr. Elizabeth Gore said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Courtesy ASTRO

The trial closed early because of slow patient accrual, however, and did not enroll enough patients to answer the primary question: whether PCI improves overall survival in patients with stage III NSCLC.

"I’d like to emphasize the need for participation in clinical trials. This is particularly important in lung cancer, which is understudied" despite its being the leading cause of cancer death in the United States, said Dr. Gore, professor of radiation oncology at the Medical College of Wisconsin, Milwaukee.

Over a median follow-up of 24.2 months for all patients and 58.6 months for living patients, the 5-year rates of brain metastases were 17.3% for those randomized to receive PCI delivered to 30 Gy in 15 fractions, compared with 26.8% for patients randomized to observation. That difference was statistically significant (P = .009).

However, there were no significant differences in the 5-year rates of survival, (26.1% for PCI and 24.6% for observation), or disease-free survival (18.5% and 14.9%, respectively).

Of the patients with treatment failures, 10% of those receiving PCI and 23% in the observation group experienced failure in the brain initially. Brain metastases (BM) were the only component of first failure in 9.1% and 21.5% of patients with and without PCI, respectively.

On multivariate analysis, PCI was significantly associated with decreased BM, whereas nonsquamous histology was associated with an increased risk of BM. The overall rate of BM in this trial was insufficient for reliable subset analyses by histology, Dr. Gore noted.

"Brain metastasis has a profound impact on patients with lung cancer in terms of quality of life. We need more information to determine which patients are most likely to derive a survival benefit from prophylactic cranial irradiation before this can become a part of standard management," she said.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

Dr. Gore and her associates have no financial disclosures.

Prophylactic cranial irradiation reduced the 5-year rate of brain metastases, but did not improve overall survival in a randomized trial that evaluated 340 patients without disease progression following potentially curative treatment for locally advanced non–small cell lung cancer.

The findings provide important confirmatory information regarding the effectiveness of prophylactic cranial irradiation (PCI) in decreasing the rate of brain failures, Dr. Elizabeth Gore said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Courtesy ASTRO

The trial closed early because of slow patient accrual, however, and did not enroll enough patients to answer the primary question: whether PCI improves overall survival in patients with stage III NSCLC.

"I’d like to emphasize the need for participation in clinical trials. This is particularly important in lung cancer, which is understudied" despite its being the leading cause of cancer death in the United States, said Dr. Gore, professor of radiation oncology at the Medical College of Wisconsin, Milwaukee.

Over a median follow-up of 24.2 months for all patients and 58.6 months for living patients, the 5-year rates of brain metastases were 17.3% for those randomized to receive PCI delivered to 30 Gy in 15 fractions, compared with 26.8% for patients randomized to observation. That difference was statistically significant (P = .009).

However, there were no significant differences in the 5-year rates of survival, (26.1% for PCI and 24.6% for observation), or disease-free survival (18.5% and 14.9%, respectively).

Of the patients with treatment failures, 10% of those receiving PCI and 23% in the observation group experienced failure in the brain initially. Brain metastases (BM) were the only component of first failure in 9.1% and 21.5% of patients with and without PCI, respectively.

On multivariate analysis, PCI was significantly associated with decreased BM, whereas nonsquamous histology was associated with an increased risk of BM. The overall rate of BM in this trial was insufficient for reliable subset analyses by histology, Dr. Gore noted.

"Brain metastasis has a profound impact on patients with lung cancer in terms of quality of life. We need more information to determine which patients are most likely to derive a survival benefit from prophylactic cranial irradiation before this can become a part of standard management," she said.

The Chicago Multidisciplinary Symposium in Thoracic Oncology is sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

Dr. Gore and her associates have no financial disclosures.

Median overall survival increased significantly among patients with stage I non–small cell lung cancer over the last decade – in particular, those treated with radiation therapy alone, according to an analysis of the Surveillance, Epidemiology, and End Results database.

The median survival for all treatment groups increased by 27%, from 44 months during 1999-2003 to 56 months during 2004-2008. For those treated with radiation alone – who would likely be the sickest patients since they would not have been considered candidates for surgery – median overall survival improved by 31%, from 16 to 21 months. Both changes were statistically significant (log rank P less than .0001).

Courtesy ASTRO

"Stage I NSCLC [non–small cell lung cancer] patients who receive radiation therapy alone are surviving longer than they used to," Dr. Nirav S. Kapadia said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

A change in the survival of patients treated with surgery could not be detected, as median survival has not yet been reached, he and his coauthors reported.

Until recently, surgery has been the primary treatment for stage I NSCLC. However, as recent advances in radiotherapy (RT) such as stereotactic body radiation therapy have allowed dose escalation with more precise tumor targeting, the use of RT has increased, and outcomes appear to have improved over time, said Dr. Kapadia, a chief resident in the department of radiation oncology at the University of Michigan, Ann Arbor

The National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database encompasses about 25% of the U.S. population. This study compared SEER data on 27,469 patients with NSCLC treated during 1999-2003 with data from 26,195 patients treated during 2004-2008.

During 1999-2003, 64% of patients were treated with primary surgery, 14% received RT alone, 20% had neither treatment, and 2% had unknown treatment. In the later era, 70% of patients underwent primary surgery, 13% received primary RT, 16% had neither surgery nor RT, and 1% had unknown treatment.

The proportion receiving surgery alone increased from 60% to 67% during the two time periods. Thus, the rates of surgery increased from the earlier to the later period, but there was no significant difference in the number of patients who received radiotherapy, either as an adjunct to surgery or as definitive therapy, noted Dr. Kapadia.

He expressed concern about the significant proportion of patients – 20% in the earlier period and 16% in the later – who did not receive surgery or radiation. "At least 16% of patients are still not getting the care that they need – care that could save their lives. We must identify the barriers to treatment so that every patient has hope for a cancer cure," he said in a statement.

For the entire study period, factors significantly associated with higher risk of death after primary RT or surgery included age, African American race, large cell or squamous histology, and being unmarried. Significant protective factors included female sex and race listed as "other."

Dr. Kapadia noted that RT is advantageous in that it is noninvasive and is done on an outpatient basis. Moreover, local control rates with radiotherapy among patients who are too sick to undergo surgery are now approaching those of surgery.

Ongoing "coin flip" studies are currently comparing outcomes of radiation versus surgery in patients who would otherwise be fit for surgery. "Those are going to be very exciting studies. ... But for right now I would say surgery is still the preferred modality, with a large body of evidence to support that statement," he said.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

Median overall survival increased significantly among patients with stage I non–small cell lung cancer over the last decade – in particular, those treated with radiation therapy alone, according to an analysis of the Surveillance, Epidemiology, and End Results database.

The median survival for all treatment groups increased by 27%, from 44 months during 1999-2003 to 56 months during 2004-2008. For those treated with radiation alone – who would likely be the sickest patients since they would not have been considered candidates for surgery – median overall survival improved by 31%, from 16 to 21 months. Both changes were statistically significant (log rank P less than .0001).

Courtesy ASTRO

"Stage I NSCLC [non–small cell lung cancer] patients who receive radiation therapy alone are surviving longer than they used to," Dr. Nirav S. Kapadia said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

A change in the survival of patients treated with surgery could not be detected, as median survival has not yet been reached, he and his coauthors reported.

Until recently, surgery has been the primary treatment for stage I NSCLC. However, as recent advances in radiotherapy (RT) such as stereotactic body radiation therapy have allowed dose escalation with more precise tumor targeting, the use of RT has increased, and outcomes appear to have improved over time, said Dr. Kapadia, a chief resident in the department of radiation oncology at the University of Michigan, Ann Arbor

The National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database encompasses about 25% of the U.S. population. This study compared SEER data on 27,469 patients with NSCLC treated during 1999-2003 with data from 26,195 patients treated during 2004-2008.

During 1999-2003, 64% of patients were treated with primary surgery, 14% received RT alone, 20% had neither treatment, and 2% had unknown treatment. In the later era, 70% of patients underwent primary surgery, 13% received primary RT, 16% had neither surgery nor RT, and 1% had unknown treatment.

The proportion receiving surgery alone increased from 60% to 67% during the two time periods. Thus, the rates of surgery increased from the earlier to the later period, but there was no significant difference in the number of patients who received radiotherapy, either as an adjunct to surgery or as definitive therapy, noted Dr. Kapadia.

He expressed concern about the significant proportion of patients – 20% in the earlier period and 16% in the later – who did not receive surgery or radiation. "At least 16% of patients are still not getting the care that they need – care that could save their lives. We must identify the barriers to treatment so that every patient has hope for a cancer cure," he said in a statement.

For the entire study period, factors significantly associated with higher risk of death after primary RT or surgery included age, African American race, large cell or squamous histology, and being unmarried. Significant protective factors included female sex and race listed as "other."

Dr. Kapadia noted that RT is advantageous in that it is noninvasive and is done on an outpatient basis. Moreover, local control rates with radiotherapy among patients who are too sick to undergo surgery are now approaching those of surgery.

Ongoing "coin flip" studies are currently comparing outcomes of radiation versus surgery in patients who would otherwise be fit for surgery. "Those are going to be very exciting studies. ... But for right now I would say surgery is still the preferred modality, with a large body of evidence to support that statement," he said.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

Median overall survival increased significantly among patients with stage I non–small cell lung cancer over the last decade – in particular, those treated with radiation therapy alone, according to an analysis of the Surveillance, Epidemiology, and End Results database.

The median survival for all treatment groups increased by 27%, from 44 months during 1999-2003 to 56 months during 2004-2008. For those treated with radiation alone – who would likely be the sickest patients since they would not have been considered candidates for surgery – median overall survival improved by 31%, from 16 to 21 months. Both changes were statistically significant (log rank P less than .0001).

Courtesy ASTRO

"Stage I NSCLC [non–small cell lung cancer] patients who receive radiation therapy alone are surviving longer than they used to," Dr. Nirav S. Kapadia said in a press briefing from the Chicago Multidisciplinary Symposium in Thoracic Oncology.

A change in the survival of patients treated with surgery could not be detected, as median survival has not yet been reached, he and his coauthors reported.

Until recently, surgery has been the primary treatment for stage I NSCLC. However, as recent advances in radiotherapy (RT) such as stereotactic body radiation therapy have allowed dose escalation with more precise tumor targeting, the use of RT has increased, and outcomes appear to have improved over time, said Dr. Kapadia, a chief resident in the department of radiation oncology at the University of Michigan, Ann Arbor

The National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database encompasses about 25% of the U.S. population. This study compared SEER data on 27,469 patients with NSCLC treated during 1999-2003 with data from 26,195 patients treated during 2004-2008.

During 1999-2003, 64% of patients were treated with primary surgery, 14% received RT alone, 20% had neither treatment, and 2% had unknown treatment. In the later era, 70% of patients underwent primary surgery, 13% received primary RT, 16% had neither surgery nor RT, and 1% had unknown treatment.

The proportion receiving surgery alone increased from 60% to 67% during the two time periods. Thus, the rates of surgery increased from the earlier to the later period, but there was no significant difference in the number of patients who received radiotherapy, either as an adjunct to surgery or as definitive therapy, noted Dr. Kapadia.

He expressed concern about the significant proportion of patients – 20% in the earlier period and 16% in the later – who did not receive surgery or radiation. "At least 16% of patients are still not getting the care that they need – care that could save their lives. We must identify the barriers to treatment so that every patient has hope for a cancer cure," he said in a statement.

For the entire study period, factors significantly associated with higher risk of death after primary RT or surgery included age, African American race, large cell or squamous histology, and being unmarried. Significant protective factors included female sex and race listed as "other."

Dr. Kapadia noted that RT is advantageous in that it is noninvasive and is done on an outpatient basis. Moreover, local control rates with radiotherapy among patients who are too sick to undergo surgery are now approaching those of surgery.

Ongoing "coin flip" studies are currently comparing outcomes of radiation versus surgery in patients who would otherwise be fit for surgery. "Those are going to be very exciting studies. ... But for right now I would say surgery is still the preferred modality, with a large body of evidence to support that statement," he said.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.