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Title: Pre-Surgery Cisplatin-Gemcitabine More Effective Than Surgery Alone in Patients With Severe Lung Cancer: Presented at ASCO
URL: http://www.pslgroup.com/dg/222AAE.htm
Doctor's Guide
June 2, 2008


By Cameron Johnston

CHICAGO -- June 2, 2008 -- Preoperative chemotherapy with gemcitabine and cisplatin appears to offer better progression-free survival (PFS) and overall survival compared with surgery alone for patients with advanced non-small-cell lung cancer (NSCLC), according to an Italian study presented at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting.

The results of the study were detailed here on June 1 in a clinical-science symposium on lung cancer by lead author Giorgio V. Scagliotti, MD, PhD, University of Turin, Department of Clinical and Biological Sciences, San Luigi Hospital, Orbassano, Turin, Italy.

The study was intended to enrol a total of 700 patients; however, when the advantage of using the preoperative chemotherapy was seen, enrolment was stopped early. The final data were based on an analysis of 129 patients who received preoperative chemotherapy and 141 patients who went straight to surgery after diagnosis.

Patients in the chemotherapy arm received 75 mg/m2 cisplatin on day 1, and 1,250 mg/m2 of gemcitabine on days 1 and 8 of a 21-day cycle.

Overall, 3-year PFS was 48% for those in the surgery-only cohort, compared with 53% for those who had preoperative chemotherapy (hazard ratio [HR] = 0.71, P = .011).

For patients who had stage IIB to IIIA disease (advanced disease) at enrolment, mean PFS was 1.1 years compared with 4.0 years for those who had surgery alone and those who had preoperative chemotherapy. Three-year PFS was 36% and 55% between the 2 groups respectively.

For patients whose cancer was in an early stage at enrolment (IB to IIA), results told a somewhat different story, Dr. Scagliotti noted. In the early-stage patients, PFS was 3.6 years in those who underwent surgery alone compared with 2.9 years for those who had preoperative chemotherapy. Essentially, there were no differences in outcomes between the 2 treatment programs in patients who had early-stage disease.

In terms of overall survival, 42% of patients in the surgery-only arm died, compared with 34% of those in the preoperative-chemotherapy arm. Median overall survival was 4.8 years for those in the surgery-only group, but was not available in the preoperative-chemotherapy arm.

Following chemotherapy, there was a 35% response rate (n = 45), which included 40 patients who had a partial response and 55 who had stable disease. Progressive disease was seen in 7 patients.
Of those who had surgery only, one-quarter had pneumonectomy.

Finally, at the end of 3 years, 60% of patients who had surgery alone were still alive, compared with 67% of those who had the preoperative cisplatin/gemcitabine. This corresponds with a hazard ratio of 0.63, P = .005.

Patients in this study were well balanced for demographic characteristics and for disease stage. Of those who received surgery alone were, 55% were stage IB to IIA, and 45% were stage IIB to IIIA. Of those who received preoperative chemotherapy, 49% were stage IB to IIA and 51% were stage IIB to IIIA.

According to Dr. Scagliotti, this study demonstrates that preoperative chemotherapy can be well tolerated and leads to better outcomes than surgery alone for patients with advanced NSCLC.
These results, he added, were not as strong as what had been seen in previous studies looking at preoperative therapies, but consideration has to be given to the fact that the study was stopped early and, therefore, data from many patients were not included in the final analysis.

[Presentation title: A Phase III Randomized Study of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early-Stage Non-Small-Cell Lung Cancer (NSCLC): Follow-Up Data of Ch.E.S.T. Abstract 7508]

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