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Long-Term Follow-Up of Patients Treated With Paclitaxel/Carboplatin-Based Chemotherapy for Advanced Non–Small-Cell Lung Cancer: Sequential Phase II Trials of the Minnie Pearl Cancer Research Network

From The Sarah Cannon Cancer Center and Tennessee Oncology, PLLC, Nashville, TN; Oncology Hematology Group of South Florida, Miami, FL; and Comprehensive Cancer Institute, Huntsville, AL.

Address reprint requests to John D. Hainsworth, MD, The Sarah Cannon Cancer Center, 250 25th Ave N, Ste 110, Nashville, TN 37203; email: jhainsworth{at}tnonc.com

PURPOSE: To provide long-term follow-up on the survival of patients with advanced non–small-cell lung cancer treated with paclitaxel/carboplatin-based regimens in a multicenter, community-based setting.

PATIENTS AND METHODS: Between March 1995 and April 1998, 321 patients with newly diagnosed stage IIIB or IV non–small-cell lung cancer were treated on sequential phase II trials with the following combination regimens: paclitaxel/carboplatin, paclitaxel/carboplatin/gemcitabine, and paclitaxel/carboplatin/vinorelbine. Details of these three regimens and patient populations have been previously reported. Responding and stable patients continued treatment until tumor progression or for a recommended six treatment courses.

RESULTS: After a median follow-up of 58 months (minimum follow-up, 40 months), the median survival for the entire group of patients was 8.6 months, with actual 1-, 2-, and 3-year survival rates of 40%, 19%, and 7%, respectively. The actuarial 4-year survival rate for the entire group was 4%. No statistically significant differences in survival were seen among the three regimens. Administration of all three regimens was feasible in a community-based setting; however, myelosuppression and hospitalizations for treatment of neutropenia/fever were more frequent with the three-drug regimens.

CONCLUSION: Paclitaxel/carboplatin-based regimens, in addition to prolonging median survival and improving 1-year survival, result in substantial improvements in the 2-year survival of patients with advanced non–small-cell lung cancer when compared retrospectively with supportive care or traditional cisplatin-based regimens. In these sequential phase II trials, we did not demonstrate any advantages of three-drug regimens when compared with paclitaxel/carboplatin. Because few patients remain alive after 4 years with any of these chemotherapy regimens, future treatment improvements will require the introduction of novel agents.

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