The combination of gemcitabine and cisplatin as neoadjuvant chemotherapy for early stage non-small cell lung carcinoma (NSCLC): an interim analysis of a phase II trial

Abstract

7303 Background: The objectives of this ongoing, open-label, single-arm, phase II trial were to evaluate the efficacy and safety of gemcitabine/cisplatin as neoadjuvant chemotherapy in patients with operable, early stage NSCLC. Methods: Chemonaive patients >18 to 70 years old with stage IB, IIA-B, and IIIA NSCLC and an ECOG performance status (PS) of 0–1 received gemcitabine (1000 mg/m2; iv) on days 1 and 8 plus cisplatin (75 mg/m2; iv) on day 1. The treatment was administered on a 21-day treatment cycle for 3 cycles, followed by surgery or radiotherapy if medically unfit for surgery. The follow-up period was 12 months after surgery. Results: At the time of this analysis, 43 patients, with a median age of 55.8 years, were enrolled. Most patients (47%) had stage IB, while 26% of the patients had stage II and 28% had stage IIIA disease. N0 and N2 nodal disease was observed in 74% and 26% of the patients, respectively. Overall, 70% of the patients had T2 primary tumors, 26% had T3, and 2% of the patients each had T1 and T0. At baseline, 19 patients had a PS of 0 and 24 patients had a PS of 1. The PS of the patients improved in each visit during the follow-up period; 33 (77%) patients were fully active and asymptomatic (PS 0) at the final visit. Of the 38 patients evaluable for clinical tumor response, 21 (55%) had partial response and 15 (40%) had stable disease, while only 2 (5%) had progressive disease. NCI-CTC grade 3–4 hematologic toxicities included neutropenia in 24 (56%) patients and thrombocytopenia in 6 (14%) patients. Non-hematologic toxicities were acceptable. Data on 24 of 43 patients were analyzed for surgery. The tumor resection rate was 88% (21 of 24). Two of 24 patients (8%) received radiotherapy following chemotherapy. Conclusion: Preliminary results show that the combination of gemcitabine/cisplatin is an effective and tolerable neoadjuvant treatment for patients with operable, early stage NSCLC. The final analysis of the data, including pathological complete response rate as well as the expression and correlation of the prognostic factors erbB-2, VEGF, Ki67, and p53 with efficacy parameters, will be presented at the meeting. No significant financial relationships to disclose.