Phase II trial of neoadjuvant chemotherapy using alternating doublets in non-small-cell lung cancer.

Purpose: Lung cancer is an epidemic disease in developing countries. Incorporation of new active drugs in the neoadjuvant treatment of operable patients might lead to improved outcomes. Postchemotherapy mediastinal-based treatment decisions allow for in vivo testing of activity and could help to determine the ideal local treatment.

Patients And Methods: This phase II trial enrolled patients with documented non-small-cell lung cancer, clinically staged IB-IIIA, and considered candidates for surgical resection. Patients received 3 cycles of neoadjuvant chemotherapy with alternating doublets: cisplatin/gemcitabine; gemcitabine/vinorelbine, and cisplatin/vinorelbine. After neoadjuvant treatment, clinical restaging was performed. Patients without evidence of progression underwent mediastinoscopy. Those with negative mediastinal nodes were taken to surgery whereas those with positive nodes were treated with radiation therapy.

Results: Between January 2001 and August 2002, 30 patients were included. The median age was 56 years, 66% of the patients were men, 43% of the patients had adenocarcinoma, and 34% had squamous cell carcinoma. Clinical staging was IB in 9 patients (30%), IIB in 7 (23%), and IIIA in 14 (47%). Median tumor size was 6.5 cm (range, 3-11 cm). Twenty-three patients (77%) had clinical response to neoadjuvant chemotherapy. Eight of 12 patients (67%) with N2 disease had clinical downstaging. Twenty-two patients (73%) were taken to surgery. Complete resection rate was achieved in 21 patients (70%). Treatment was well tolerated.

Conclusion: Localized non-small-cell lung cancer is very sensitive to chemotherapy. Postchemotherapy mediastinal-based treatment decision led to a high complete resection rate, even in patients with large tumors. This strategy deserves further investigation.