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Induction Docetaxel and Carboplatin Followed by Weekly Docetaxel and Carboplatin with Concurrent Radiotherapy, then Surgery in Stage III Non-Small Cell Lung Cancer

A Phase I Study¹

Departments of Adult Oncology, Surgery, and Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts 02115 [L. J. W., J. L., C. L., P. A. J., B. E. J., A. T. S.]; Massachusetts General Hospital, Boston, Massachusetts [P. O., P. F., D. J. M., N. C. C.]; Brigham and Women’s Hospital, Boston, Massachusetts [D. J. S., J. M. L.]; M. D. Anderson Cancer Center, Houston, Texas; and Beth Israel Deaconess Medical Center, Boston, Massachusetts [S. M. B.]

Purpose: To determine the maximum-tolerated dose of docetaxel (DOC) in combination with carboplatin (CAR) and thoracic radiotherapy (RT), in the setting of trimodality treatment of patients with stage III non-small cell lung cancer (NSCLC).

Experimental Design: Thirty-two patients with biopsy-proven stage IIIA (n = 20) or IIIB (n = 12) NSCLC were given two initial cycles of CAR (area under the curve = 6) and DOC (75 mg/m²), subsequent RT (54 Gy) with concurrent weekly CAR (area under the curve = 2), and DOC at six dose levels from 10 to 40 mg/m², then surgery if the patient’s disease was resectable.

Results: Three patients did not complete induction computed tomography (CT). Twenty-nine patients received concurrent CT/RT. Fifteen patients were eligible for surgery. Dose-limiting toxicities occurred in 2 patients, at dose levels two (atrial fibrillation) and three (transaminitis). The maximum-tolerated dose, as defined by the protocol, was not reached, although grade 3 and 4 toxicities were encountered at all dose levels. The most common more than or equal to grades 3 toxicities were neutropenia, nausea, vomiting, and fatigue. Four patients (13.3%) responded to induction CT. Ten patients (38.5%) responded to CT/RT. Eight surgical patients (57.1%) were downstaged, including 3 pathologic complete responses. Median relapse free and overall survivals are 8.5 and 12 months. One-year and estimated 2-year survival rates are 56.3 and 34.3%.

Conclusion: This new regimen for stage III NSCLC of induction CAR/DOC, then weekly CAR/DOC with concurrent RT followed by surgery, can be safely administered and offers encouraging results. DOC at 30 mg/m² in combination with CAR and RT is recommended for Phase II study.

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				A. Cesario, S. Margaritora, D. Galetta, V. Porziella, P. Granone, R. M. D'Angelillo, L. Trodella, V. Cardaci, S. Sterzi, and P. Russo Correspondence re L. J. Wirth et al., Induction Docetaxel and Carboplatin Followed by Weekly Docetaxel and Carboplatin with Concurrent Radiotherapy, Then Surgery in Stage III Non-Small Cell Lung Cancer: a Phase I Study. Clin Cancer Res 2003;9:1698-704. Clin. Cancer Res., April 15, 2004; 10(8): 2902 - 2903. [Full Text] [PDF]

				L. J. Wirth, A. T. Skarin, and D. J. Sugarbaker Reply Clin. Cancer Res., April 15, 2004; 10(8): 2904 - 2904. [Full Text] [PDF]