Gemcitabine and oxaliplatin (GEMOX), a promissing combination for the treatment of relapsed, advanced or metastatic non small cell lung cancer (NSCLC)

Abstract

19061 Background: Combination of Gemcitabine and Oxaliplatin (GEMOX) given every 3 weeks was reported to be safe and active in phase II studies in first and second line therapy of NSCLC. The aim of our trial was to assess the efficacy and safety of oxaliplatin in combination with fixed rate infusion gemcitabine in the second and third line treatment of NSCLC, and to assess quality of life (QOL). Methods: 30 patients with advanced NSCLC, with Performance status (PS) ECOG 0–1, and who had failed first or second line treatment with chemotherapy and/or tyrosine kinase inhibitors were treated with GEM 1,000 mg/m2 over 100 min in combination with O× 100 mg/m2 over 2 hours both given on days 1 and 15 of each 28-day cycle. Primary endpoint was ORR and secondary endpoints were toxicity, time to tumor progression, time to treatment failure, overall survival. QOL was assessed by the FACT-L V.4 and Lung Cancer Subscale (LCS) questionnaires. Results: From the 30 patients, 16 (53%) were males and 14 (47%) females. 20 patients were Hispanics (66%), 7 Caucasian (23%), 3 African American (10%). Median age was 56 years. PS was ECOG 0 and 1 in 14(47%) and 16(53%) respectively. Histological subtypes were adenocarcinoma in 14 patients (47%), adeno-squamos in 1(3%), squamos in 3(1%), Bronchoalveolar carcinoma in 2 (6%) and unspecified in 9 (30%) patients. The treatment was second line for 22 (73%) patients and third line for 7(23%) patients. 1 patient progressed quickly and became ineligible for the treatment after enrollment. Two patients died on study from disease progression leading to respiratory and multi-organ failure. Partial responses were achieved in 4 (13%) patients, stable disease in 12 (40%) and progressive disease in 12 (40%). Grade 3/4 adverse events were seen in <10% of the patients and included fatigue, dyspnea, anemia and multiorgan failure (1 patient). There was a 25% improvement in the QOL LCS score. Conclusion: GEMOX combination given in day 1 and 15 of every 4 weeks shows activity and tolerable side effects when used to treat patients with advanced NSCLC who have previously failed chemotherapy, tirosine kinase or angiogenesis inhibitors, with a suggestion of QOL improvement. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Lilly Oncology, sanofi-aventis sanofi-aventis