Paclitaxel and carboplatin as neoadjuvant chemotherapy in operable (stage I and II) and locally advanced (stage IIIA-N2) non-small cell lung cancer.

In 1995, a randomized intergroup study of neoadjuvant chemotherapy followed by either surgery or radiotherapy in the treatment of non-small cell lung cancer was started under the auspices of the European Organization for Research and Treatment of Cancer (EORTC 08941). The objective of this study is to investigate whether surgery or radiotherapy represents superior locoregional treatment, in terms of survival and quality of life, for patients with stage IIIA(N2) non-small cell lung cancer who have achieved a response after three courses of neoadjuvant chemotherapy. A phase II side study will investigate the clinical and pathologic response rate (if applicable), as well as acute and late side effects during or after consecutive surgery and/or radiotherapy of combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin. It is planned that paclitaxel 175 mg/m2 will be given as a 3-hour infusion, followed by a 30-minute infusion of carboplatin at a dose based on a target area under the concentration-time curve of 6 mg x min/mL. This phase II study was started in October 1996. Depending on the response rate and early and late side effects observed in this well-defined, prognostically favorable group of patients, it will be decided whether and how to use the same combination chemotherapy in an ongoing randomized trial currently being conducted by the Dutch Lung Cancer Study Group (DLCSG 94-2). In the latter trial, patients with stage I and II non-small cell lung cancer are randomized to immediate surgery or two courses of neoadjuvant chemotherapy. Responding patients will receive another two courses of chemotherapy before surgery; nonresponders will go directly to surgery.