Weekly paclitaxel in advanced non-small cell lung cancer

Alex Y Chang, Jonathan Rubins, Robert Asbury, Laszlo Boros, Fong Hui Lai Fong Hui

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)10-13
Number of pages4
JournalSeminars in Oncology
Volume28
Issue number4 SUPPL. 14
StatePublished - 2001
Externally publishedYes

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Paclitaxel
Non-Small Cell Lung Carcinoma
Peripheral Nervous System Diseases
Drug Therapy
Survival
Maximum Tolerated Dose
Neutropenia
Hyperglycemia
Fatigue
Blood Glucose
Appointments and Schedules
Survival Rate
Confidence Intervals
Infection

ASJC Scopus subject areas

  • Oncology

Cite this

Chang, A. Y., Rubins, J., Asbury, R., Boros, L., & Lai Fong Hui, F. H. (2001). Weekly paclitaxel in advanced non-small cell lung cancer. Seminars in Oncology, 28(4 SUPPL. 14), 10-13.

Weekly paclitaxel in advanced non-small cell lung cancer. / Chang, Alex Y; Rubins, Jonathan; Asbury, Robert; Boros, Laszlo; Lai Fong Hui, Fong Hui.

In: Seminars in Oncology, Vol. 28, No. 4 SUPPL. 14, 2001, p. 10-13.

Research output: Contribution to journalArticle

Chang, AY, Rubins, J, Asbury, R, Boros, L & Lai Fong Hui, FH 2001, 'Weekly paclitaxel in advanced non-small cell lung cancer', Seminars in Oncology, vol. 28, no. 4 SUPPL. 14, pp. 10-13.
Chang AY, Rubins J, Asbury R, Boros L, Lai Fong Hui FH. Weekly paclitaxel in advanced non-small cell lung cancer. Seminars in Oncology. 2001;28(4 SUPPL. 14):10-13.
Chang, Alex Y ; Rubins, Jonathan ; Asbury, Robert ; Boros, Laszlo ; Lai Fong Hui, Fong Hui. / Weekly paclitaxel in advanced non-small cell lung cancer. In: Seminars in Oncology. 2001 ; Vol. 28, No. 4 SUPPL. 14. pp. 10-13.
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abstract = "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.",
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