TY - JOUR
T1 - NCCTG N0821 (Alliance)
T2 - A phase ii first-line study of pemetrexed, carboplatin, and bevacizumab in elderly patients with advanced nonsquamous non-small-cell lung cancer with good performance status
AU - Dy, Grace K.
AU - Molina, Julian R.
AU - Qi, Yingwei
AU - Ansari, Rafat
AU - Thomas, Sachdev
AU - Ross, Helen J.
AU - Soori, Gamini
AU - Anderson, Daniel
AU - Christine Aubry, Marie
AU - Meyers, Jeffrey
AU - Adjei, Araba A.
AU - Mandrekar, Sumithra
AU - Adjei, Alex A.
N1 - Funding Information:
This study was conducted as a collaborative trial of the North Central Cancer Treatment Group, Mayo Clinic and the Alliance and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-63849, CA-35113, CA-35267, CA-35269, CA-35103, CA-35415, CA-35090, and CA-63848 from the National Cancer Institute, Department of Health and Human Services. The content is solely the responsibility of the authors and does not necessarily represent the views of the National Cancer Institute or the National Institute of Health. The results of this study had been presented in a poster session in the 12 th Annual meeting of the American Society of Clinical Oncology in June 2012.
PY - 2014/8
Y1 - 2014/8
N2 - Background: We hypothesized that the combination of bevacizumab, carboplatin, and pemetrexed will be an effective first-line regimen in fit, elderly patients with nonsquamous non-small-cell lung cancer . Methods: Treatment-naïve, stage IIIB/IV nonsquamous non-smallcell lung cancer patients more than 70 years old with good performance status (Eastern Cooperative Oncology Group performance status 0-1) and adequate organ function were eligible. Carboplatin area under the curve 6, pemetrexed 500 mg 2, and bevacizumab 15 mg/kg were administered on day 1 of each 21-day cycle (up to six cycles) followed by maintenance pemetrexed and bevacizumab. The primary end point of 6-month progression-free survival rate of at least 70% was assessed using a one-stage binomial design. Quality of life (QOL) questionnaires were administered. Polymorphisms in genes encoding relevant proteins (drug targets, transport, and metabolism proteins) were correlated with treatment outcome. Results: Fifty-seven eligible patients were enrolled. Median age was 74.5 years. Median treatment cycles received was 6. The most common grade 3 or higher non-hematologic adverse events were fatigue (26%) and hypertension (11%); 16% had grade 4 neutropenia and 6.5% had grade 4 thrombocytopenia. Three patients experienced grade 3/4 hemorrhagic events (one pulmonary, two gastrointestinal). Primary end point of PFS6 was 60% (95% confidence interval [CI]: 45.9-73%). Median PFS was 7.0 months (95% CI: 5.9-10.1), median overall survival was 13.7 months (95% CI: 9.4-16.8). Polymorphic KDR and VEGFA variants correlated with survival and toxicity, respectively. There was no significant change in overall QOL scores over time. Conclusion: This regimen is feasible and did not decrease the QOL in this study population. However, it did not meet the primary efficacy end point.
AB - Background: We hypothesized that the combination of bevacizumab, carboplatin, and pemetrexed will be an effective first-line regimen in fit, elderly patients with nonsquamous non-small-cell lung cancer . Methods: Treatment-naïve, stage IIIB/IV nonsquamous non-smallcell lung cancer patients more than 70 years old with good performance status (Eastern Cooperative Oncology Group performance status 0-1) and adequate organ function were eligible. Carboplatin area under the curve 6, pemetrexed 500 mg 2, and bevacizumab 15 mg/kg were administered on day 1 of each 21-day cycle (up to six cycles) followed by maintenance pemetrexed and bevacizumab. The primary end point of 6-month progression-free survival rate of at least 70% was assessed using a one-stage binomial design. Quality of life (QOL) questionnaires were administered. Polymorphisms in genes encoding relevant proteins (drug targets, transport, and metabolism proteins) were correlated with treatment outcome. Results: Fifty-seven eligible patients were enrolled. Median age was 74.5 years. Median treatment cycles received was 6. The most common grade 3 or higher non-hematologic adverse events were fatigue (26%) and hypertension (11%); 16% had grade 4 neutropenia and 6.5% had grade 4 thrombocytopenia. Three patients experienced grade 3/4 hemorrhagic events (one pulmonary, two gastrointestinal). Primary end point of PFS6 was 60% (95% confidence interval [CI]: 45.9-73%). Median PFS was 7.0 months (95% CI: 5.9-10.1), median overall survival was 13.7 months (95% CI: 9.4-16.8). Polymorphic KDR and VEGFA variants correlated with survival and toxicity, respectively. There was no significant change in overall QOL scores over time. Conclusion: This regimen is feasible and did not decrease the QOL in this study population. However, it did not meet the primary efficacy end point.
KW - Bevacizumab
KW - Elderly
KW - Non-small cell lung cancer
KW - Nonsquamous histology
KW - Survival
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UR - http://www.scopus.com/inward/citedby.url?scp=84905823267&partnerID=8YFLogxK
U2 - 10.1097/JTO.0000000000000217
DO - 10.1097/JTO.0000000000000217
M3 - Article
C2 - 25157767
AN - SCOPUS:84905823267
SN - 1556-0864
VL - 9
SP - 1146
EP - 1153
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 8
ER -