PMID- 15949597 OWN - NLM STAT- MEDLINE DCOM- 20051201 LR - 20221207 IS - 0169-5002 (Print) IS - 0169-5002 (Linking) VI - 49 IP - 1 DP - 2005 Jul TI - Sequential therapy with Vinorelbine followed by Gemcitabine in patients with metastatic non small cell lung cancer (NSCLC), performance status (PS) 2, or elderly with comorbidities--a multicenter phase II trial. PG - 117-23 AB - BACKGROUND: High risk patients with metastatic non small cell lung cancer (NSCLC) including patients with performance status (PS) 2 or elderly with comorbidities do poorly on combination chemotherapy regimens. We evaluated a sequential treatment with Vinorelbine followed by Gemcitabine to determine its effect on survival and the toxicity in this patient population. METHODS: Forty-two evaluable patients, median age 75, 21 patients with PS 2 and 21 patients with PS 0 or 1, 37 patients with stage IV and five patients with stage III B NSCLC entered the trial. They received Vinorelbine 30 mg/m2, i.v., on days 1+8 every 3 weeks followed by Gemcitabine 1000 mg/m2, i.v., on days 1+8 every 3 weeks, each for two cycles for stable disease or one cycle after best response. Then stable patients continued until progressive disease on Vinorelbine or Gemcitabine according to the patient's preference. RESULTS: A total of 126 cycles of Vinorelbine were administered to 42 patients, median of three cycles per patient and 74 cycles of Gemcitabine, median of 1.0 cycle per patient. Sixteen patients (38%) achieved PR, 11 patients on Vinorelbine, 5 patients on Gemcitabine; 12 patients (26%) had stable disease, 7 patients on Vinorelbine, 5 patients on Gemcitabine. Of 24 patients with progressive disease on Vinorelbine, 3 patients (12.5%) responded to Gemcitabine. Median time-to-first progression was 3.5 months, median survival was 8 months, 1-year survival was 12 patients (28.5%). No grade 3 or 4 toxicities were reported. CONCLUSION: This sequential treatment offers excellent palliative treatment with minimal toxicity for high-risk patients with metastatic NSCLC. FAU - Hirsh, Vera AU - Hirsh V AD - Royal Victoria Hospital, McGill University, 687 Pine Avenue W, Montreal, Que., Canada H3A 1A1. vera.hirsh@muhc.mcgill.ca FAU - Latreille, Jean AU - Latreille J FAU - Kreisman, Harvey AU - Kreisman H FAU - Desjardins, Pierre AU - Desjardins P FAU - Ofiara, Linda AU - Ofiara L FAU - Whittom, Renaud AU - Whittom R FAU - Fox, Susan AU - Fox S FAU - Palayew, Mark David AU - Palayew MD FAU - Pintos, Javier AU - Pintos J LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20050216 PL - Ireland TA - Lung Cancer JT - Lung cancer (Amsterdam, Netherlands) JID - 8800805 RN - 0W860991D6 (Deoxycytidine) RN - 5V9KLZ54CY (Vinblastine) RN - Q6C979R91Y (Vinorelbine) RN - 0 (Gemcitabine) SB - IM MH - Adult MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/complications/*radiotherapy MH - Comorbidity MH - Deoxycytidine/administration & dosage/analogs & derivatives MH - Drug Administration Schedule MH - Female MH - *Frail Elderly MH - Humans MH - Infusions, Intravenous MH - Lung Neoplasms/complications/*radiotherapy MH - Male MH - Middle Aged MH - Palliative Care MH - Risk Factors MH - Survival Analysis MH - Treatment Outcome MH - Vinblastine/administration & dosage/analogs & derivatives MH - Vinorelbine MH - Gemcitabine EDAT- 2005/06/14 09:00 MHDA- 2005/12/13 09:00 CRDT- 2005/06/14 09:00 PHST- 2004/07/28 00:00 [received] PHST- 2004/11/17 00:00 [revised] PHST- 2004/11/23 00:00 [accepted] PHST- 2005/06/14 09:00 [pubmed] PHST- 2005/12/13 09:00 [medline] PHST- 2005/06/14 09:00 [entrez] AID - S0169-5002(04)00623-3 [pii] AID - 10.1016/j.lungcan.2004.11.029 [doi] PST - ppublish SO - Lung Cancer. 2005 Jul;49(1):117-23. doi: 10.1016/j.lungcan.2004.11.029. Epub 2005 Feb 16.