TY - JOUR
T1 - Weekly paclitaxel in advanced non-small cell lung cancer
AU - Alex Yuang-Chi Chang, Yuang-Chi Chang
AU - Rubins, Jonathan
AU - Asbury, Robert
AU - Boros, Laszlo
AU - Lai Fong Hui, Fong Hui
N1 - Funding Information:
From Johns Hopkins Singapore Clinical Services, Singapore; and Interlakes Hematology Oncology Inc, Rochester NY. Dr Chang has received honoraria from Bristol-Myers Squibb, Eli Lilly, and Serene and research grant support fv.xn Bristol-Myers Squibb, Eli Lilly, AstraZeneca, and Merck AG. Dr Asbury has received research grant support from Bristol-Myers Squibb. Address reent requests to Alex Yuang-Chi Chang, MD, Johns Hopkins-NUH International Medical Center, 5 Lower Kent Ridge Rood, Level 8, Kent Ridge Wing, Nafiomal Universiry Hospital, Singapore 119074. Copyright 0 2001 by W.B. Saunders Company 0093.7754101/2804-1403$35.00/O doi:lO. 1053/sonc.2001.27607
PY - 2001
Y1 - 2001
N2 - Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is one of the most commonly used agents in treating patients with locally advanced and metastatic non-small cell lung cancer (NSCLC). It is usually given once every 3 weeks. We have evaluated paclitaxel given once per week for 3 weeks every 4 weeks for patients with recurrent or metastatic NSCLC. Two consecutive studies using weekly paclitaxel were performed. The first study was a dose-escalation study with paclitaxel beginning at 50 mg/m2 days 1, 8, and 15 every 4 weeks. Subsequent dose escalation was performed with 10 mg/m2 increments per week. The second phase II study used paclitaxel at 80 mg/m2 days 1, 8, and 15 every 4 weeks. The phase I study showed that the maximum tolerated dose was 90 mg/m2/wk for 3 weeks with 1 week off. The efficacy and side effects of both phase I and II were quite similar; therefore, the results were combined. Seventeen patients were in the phase I and 30 patients in the phase II study. The mean age was 72 years. Twenty-three patients had Eastern Cooperative Oncology Group performance status of 2 and 16 patients had received prior chemotherapy. One complete and 13 partial responses were observed with response duration ranging from 1 to 18+ months. Overall response rate was 30% (95% confidence interval, 18.5% to 42%). Overall median survival was 184 days. Grade 3/4 neutropenia was 8.5%, grade 3/4 infections was 6.4%, and grade 2 peripheral neuropathy was also 6.4%. Hyperglycemia with random blood sugar levels greater than 250 mg/dL was 6.4% and grade 3 fatigue was 4.3%. In general, treatment was well tolerated. In the best prognostic group of 16 patients without prior chemotherapy and with performance status 0 to 1, the response rate was 37.5% with a 1-year survival rate of 44% and median survival of 305 days. Prior chemotherapy, poor performance status, age higher than 70 years, and male gender carried a worse prognosis. In both phase I and II studies we observed limited myelosuppression, peripheral neuropathy, and constitutional symptoms. Weekly paclitaxel, delivered at our schedule, is an active and well-tolerated regimen. The role of weekly paclitaxel in NSCLC should be better defined in future randomized studies.
AB - Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is one of the most commonly used agents in treating patients with locally advanced and metastatic non-small cell lung cancer (NSCLC). It is usually given once every 3 weeks. We have evaluated paclitaxel given once per week for 3 weeks every 4 weeks for patients with recurrent or metastatic NSCLC. Two consecutive studies using weekly paclitaxel were performed. The first study was a dose-escalation study with paclitaxel beginning at 50 mg/m2 days 1, 8, and 15 every 4 weeks. Subsequent dose escalation was performed with 10 mg/m2 increments per week. The second phase II study used paclitaxel at 80 mg/m2 days 1, 8, and 15 every 4 weeks. The phase I study showed that the maximum tolerated dose was 90 mg/m2/wk for 3 weeks with 1 week off. The efficacy and side effects of both phase I and II were quite similar; therefore, the results were combined. Seventeen patients were in the phase I and 30 patients in the phase II study. The mean age was 72 years. Twenty-three patients had Eastern Cooperative Oncology Group performance status of 2 and 16 patients had received prior chemotherapy. One complete and 13 partial responses were observed with response duration ranging from 1 to 18+ months. Overall response rate was 30% (95% confidence interval, 18.5% to 42%). Overall median survival was 184 days. Grade 3/4 neutropenia was 8.5%, grade 3/4 infections was 6.4%, and grade 2 peripheral neuropathy was also 6.4%. Hyperglycemia with random blood sugar levels greater than 250 mg/dL was 6.4% and grade 3 fatigue was 4.3%. In general, treatment was well tolerated. In the best prognostic group of 16 patients without prior chemotherapy and with performance status 0 to 1, the response rate was 37.5% with a 1-year survival rate of 44% and median survival of 305 days. Prior chemotherapy, poor performance status, age higher than 70 years, and male gender carried a worse prognosis. In both phase I and II studies we observed limited myelosuppression, peripheral neuropathy, and constitutional symptoms. Weekly paclitaxel, delivered at our schedule, is an active and well-tolerated regimen. The role of weekly paclitaxel in NSCLC should be better defined in future randomized studies.
UR - http://www.scopus.com/inward/record.url?scp=0034786856&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034786856&partnerID=8YFLogxK
U2 - 10.1053/sonc.2001.27607
DO - 10.1053/sonc.2001.27607
M3 - Article
C2 - 11605177
AN - SCOPUS:0034786856
SN - 0093-7754
VL - 28
SP - 10
EP - 13
JO - Seminars in oncology
JF - Seminars in oncology
IS - 4 SUPPL. 14
ER -