Phase II Study of Weekly Paclitaxel in Patients with Non-Small Cell Lung Cancer Who Have Failed Previous Treatments

• Published in: Oncology Vol. 66; no. 5; pp. 347 - 352
• Main Authors: Yasuda, Kazuhito, Igishi, Tadashi, Kawasaki, Yuji, Kato, Kazuhiro, Matsumoto, Shingo, Katayama, Satoru, Sako, Takanori, Shigeoka, Yasushi, Suyama, Hisashi, Sugitani, Akinori, Yamamoto, Mistunobu, Hitsuda, Yutaka, Shimizu, Eiji
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland Karger 01.01.2004; S. Karger AG
• Subjects: Adult; Aged; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; Antineoplastic Agents, Phytogenic - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Clinical Study; Clinical trials; Drug therapy; Female; Humans; Lung cancer; Lung Neoplasms - drug therapy; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - therapeutic use; Pneumology; Survival Analysis; Treatment Failure; Treatment Outcome; Tumors; Tumors of the respiratory system and mediastinum; Second-line treatment; Weekly paclitaxel; Non-small cell lung cancer; Phase II trial; Antineoplastic agent; Human; Lung disease; Respiratory disease; Lung cancer; Malignant tumor; non-small cell lung carcinoma; Cancerology; Taxane derivatives; Paclitaxel; Bronchus disease; Second line treatment
• ISSN: 0030-2414; 1423-0232
• DOI: 10.1159/000079481

Objective: New effective therapy is desirable for patients with non-small cell lung cancer (NSCLC) who have failed previous treatments. Fractionated administration of paclitaxel may be less toxic and more active against NSCLC. The aim of this study was to evaluate the activity and toxicity of weekly paclitaxel therapy for NSCLC in a second-line setting. Methods: Patients with pathological or cytological diagnosis of NSCLC, measurable lesions, and one or more prior therapies were enrolled. We administered weekly infusions of 80 mg/m 2 paclitaxel 3 times in a 4-week cycle. In the absence of progressive disease or intolerable toxicity, each patient was treated for a minimum of 4 cycles. Results: Of 39 patients enrolled, 1 patient achieved complete response and 11 patients achieved partial response (response rate, 31%: 95% confidence interval, 17–48%). The median survival time was 43 weeks (range, 7–128 weeks). Grade 3 or 4 leukopenia occurred in only 7 patients (18%). Neurotoxicity was the most frequent adverse effect (grades 1 and 2.26 and 5%, respectively). Although all patients recovered rapidly with corticosteroid treatment, drug-induced pneumonitis was observed in 3 patients (8%). Conclusion: Low-dose weekly paclitaxel is a promising therapy with high effectiveness for advanced NSCLC in patients with NSCLC who have failed previous treatments.