First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer: A quality of life directed phase II randomized trial of Gruppo Oncologico Italia Meridionale

Purpose To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non–small-cell lung cancer NSCLC. Patients and Methods Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m2 plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m2 on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles. The primary end point was health-related quality of life (HRQoL) defined as global quality of life, nausea/vomiting, dyspnea, and fatigue reported on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the lung cancer–specific module LC13 during the first 20 weeks. Secondary end points were overall survival and toxicity. Results Four hundred thirty-six eligible patients were enrolled from April 2005 to July 2006. Patients who completed the baseline questionnaire were analyzed for HRQoL (n = 427), and those who received ≥ one cycle of chemotherapy were analyzed for toxicity (n = 423). Compliance of HRQoL questionnaires was 87%. There were no significant differences for the primary HRQoL end points or in overall survival between the two treatment arms (pemetrexed/carboplatin, 7.3 months; gemcitabine/carboplatin, 7.0 months; P = .63). The patients who received gemcitabine/carboplatin had more grade 3 to 4 hematologic toxicity than patients who received pemetrexed/carboplatin, including leukopenia (46% v 23%, respectively; P < .001), neutropenia (51% v 40%, respectively; P = .024), and thrombocytopenia (56% v 24%, respectively; P < .001). More patients on the gemcitabine/carboplatin arm received transfusions of RBCs and platelets, whereas the frequencies of neutropenic infections and thrombocytopenic bleedings were similar on both arms. Conclusion Pemetrexed/carboplatin provides similar HRQoL and survival when compared with gemcitabine/carboplatin with less hematologic toxicity and less need for supportive care.

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Duration of Chemotherapy in Advanced Non–Small-Cell Lung Cancer: A Randomized Trial of Three Versus Six Courses of Mitomycin, Vinblastine, and Cisplatin

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.5.1336 ◽

2001 ◽

Vol 19 (5) ◽

pp. 1336-1343 ◽

Cited By ~ 238

Author(s):

Ian E. Smith ◽

Mary E.R. O’Brien ◽

Denis C. Talbot ◽

Marianne C. Nicolson ◽

Janine L. Mansi ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Small Cell Lung Cancer ◽

Randomized Trial ◽

Cell Lung Cancer ◽

Symptom Relief ◽

Small Cell ◽

Life Assessment ◽

Small Cell Lung

PURPOSE: So far there are no published data on optimal duration of chemotherapy for advanced non–small-cell lung cancer (NSCLC); six or more courses are usually recommended. We have carried out a multicenter randomized trial comparing three versus six courses of chemotherapy. PATIENTS AND METHODS: Patients with stage IIIb or IV NSCLC were randomized at start of treatment to receive either three or six courses of mitomycin 8 mg/m2 (courses 1, 2, 4, and 6), vinblastine 6 mg/m2, and cisplatin 50 mg/m2 (MVP) every 21 days. Treatment was stopped early in both arms for progressive disease or unacceptable toxicity. Key end points were overall survival, duration of symptom relief, and quality-of-life assessment using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 with lung cancer–specific module QLQ-LC13. RESULTS: Three hundred eight patients were randomized. Seventy-two percent of the 155 patients randomized to three courses completed treatment. In the 153 patients randomized to six courses, 73% completed three courses and 31% six courses. Median survival was 6 versus 7 months, respectively, and 1-year survival 22% versus 25% (P = .2). Median duration of symptom relief was 4.5 months (both arms), and 8% versus 18% had continuing symptom relief (P = .4). Quality-of-life parameters were the same or improved for patients randomized to only three courses, including significantly decreased fatigue (P = .03) and a trend toward decreased nausea and vomiting (P = .06). CONCLUSION: Our findings show no evidence for additional clinical benefit by continuing MVP chemotherapy beyond three courses. This challenges current orthodoxy of six courses or more. Further trials addressing duration of chemotherapy are now warranted, particularly with newer chemotherapy schedules.

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