Guangzhou, China- 4 Nov - 7 Nov, 2005
RANDOMIZED PHASE III STUDY OF DOCETAXEL VERSUS VINORELBINE FOR ELDERLY PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (WJTOG9904)
Toshiyuki Sawa, Shinzoh Kudoh, Hiroshi Senba, Tetsu Shinkai, Isao Gotoh, Hiroshi Saito, Kenji Eguchi, Yoshiyuki Akiyama, Masahiro Fukuoka, West Japan Thoracic Oncology Group
Background Monotherapy of vinorelbine is currently standard treatment for elderly patients with advanced NSCLC. docetaxel has also shown promising results against elderly patients in our phase II study. We conducted randomized phase III trial to evaluate whether docetaxel provided better overall survival (OS) than vinorelbine.
Methods: Eligibility included more than 70 years old, NSCLC, stage IIIB or IV, and performance status (PS) of 0 to 2. Patients were randomized to receive either docetaxel (60 mg/m2, day 1) or vinorelbine (25 mg/m2, days 1, 8), repeated every 21 days over four cycles.
Results: A total of 182 patients were enrolled. Median age was 76 years. Baseline characteristics in each arm were well balanced. Median numbers of cycles were four and three in docetaxel and vinorelbine arms, respectively. Major toxicity was neutropenia in both arms, grade 3-4 neutropenia developed 83.0% and 69.2% in docetaxel and vinorelbine arms, respectively (p=0.031). Toxicity was mild and well tolerated in each arm. Response rate were 22.7% and 9.9% in docetaxel and vinorelbine, respectively (p=0.019). OS was not significantly prolonged for docetaxel (MST; 14.3 months) compared with for vinorelbine (MST; 9.9 months). The statistically better progression free survival was also observed in docetaxel arm (median PFS; 5.4 months in docetaxel, 3.1 months in vinorelbine, p<0.001). In addition, QOL study showed that two out of 8 items as disease related symptom were improved in docetaxel arm.
Conclusion: This study shows a modest, but not statistically significant improvement in survival for docetaxel. The monotherapy of docetaxel is considered as a standard treatment for elderly patients with advanced NSCLC.
オープニングセレモニーでの中国曲芸
SURVIVAL BENEFIT AND EFFICACY OF PROPHYLACTIC SHAKUYAKU-KANZOU-TO FOR MYALGIA/ARTHRALGIA FOLLOWING CARBOPLATIN AND PACLITAXEL COMBINATION CHEMOTHERAPY FOR NON-SMALL CELL LUNG CANCER
Tomoyasu Mimori, Toshiyuki Sawa, Tsutomu Yoshida, Takashi Ishiguro, Akane Horiba, Norihiko Funaguchi, Masahiro Sawada, Yasushi Ohno, Hisayoshi Fujiwara
Division of Pulmonary Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan
Background Carboplatin and Paclitaxel combination chemotherapy is one of the standard regimens for advanced non-small cell lung cancer, while myelosupression and myalgia/arthralgia are main adverse effects. Shakuyaku-Kanzou-To is suggested to be useful to control myalgia/arthralgia induced by Paclitaxel.
Objectives and Method To evaluate the efficacy of Shakuyaku-Kanzou-To on myalgia/arthralgia, a comparative study was carried out in fifty patients with non-small cell lung cancer. Patients were treated with more than 2 cycles of Carboplatin (300-400mg/m2, or AUC5-6, day 1) + Paclitaxel (180-210mg/m2, day 1). Patients were assigned alternatively to two groups supported with prophylactic Shakuyaku-Kanzou-To and with only symptomatic NSAIDs. In the prophylactic Shakuyaku-Kanzou-To group, 7.5g/day of oral Shakuyaku-Kanzou-To was administered preventively through the chemotherapy. Myalgia/arthralgia was classified into NCI-CTC grade and evaluated with score of grade by days.
Result 1) Severity of myalgia/arthralgia was not significantly improved in the group with prophylactic Shakuyaku-Kanzou-To compared with the control group, while prophylactic Shakuyaku-Kanzou-To decreased score of grade by days. In the prophylactic Shakuyaku-Kanzou-To group, additional NSAIDs medication was significantly reduced.
2) Adverse effect of Shakuyaku-Kanzou-To was not observed, while hemorrhagic duodenal ulcer induced by NSAIDs was complicated in one patient.
3) Anti-tumor response showed overall response rate at 40% in prophylactic Shakuyaku-Kanzou-To and 16% in control group. MST was 12 months in prophylactic Shakuyaku-Kanzou-To and 10 months in control group respectively.
Conclusion It is concluded that symptomatic treatment with NSAIDs and prophylactic treatment with Shakuyaku-Kanzou-To is useful to myalgia/arthralgia induced by Carboplatin and Paclitaxel combination chemotherapy and result survival benefit.
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