Gemcitabine-cisplatin as neoadjuvant therapy in locally advanced non-small-cell lung cancer : a phase II trial from Kuwait

Abstract EN

Purpose : the aim of this study is to evaluate the clinical efficacy and toxicity of gemcitabine plus cisplatin combination therapy in patients with locally advanced, unrespectable, stage III non-small-cell lung cancer (NSCLC).

Patients and Methods: Between January 1998 and January 2000, forty previously untreated patients with stage III pathologically confirmed NSCLC were enrolled into the study.

The median age of the patients was 51 years (range 33-70 years), 34 were males and 6 female patients with male to female ratio 5.6 to 1 and a World Health Organization (WHO) performance status (PS) of 0 to 2 {0 for 12 patients, 1 for 24 patients and 2 for 4 patients}.

Twenty-three patients had stage IIIA and 17 patients had stage IIIB without pleural effusion or supraclavicular lymph node metastasis.

The predominant histology was squamous cell carcinoma (19 patients) adenocarcinoma (14 patients) and large cell carcinoma (7 patients).

All eligible patients were allocated to receive induction chemotherapy with gemcitabine 1200 mg / m2 on days 1,8 and 15 plus cisplatin 100 mg / m2 (GEM-CIS) on day 15 of each 28 days cycle.

Three cycles were administered followed by surgery and / or radiation therapy in the form of 60 Gys over 6 weeks to the tumor bed and regional lymph nodes.

All patients have been followed for a median follow up period of 18 months (range12-24) months.

Results: Among the 40 patients who received the GEM-CIS combination there were three complete responses (7.5 %) and 23 partial responses (57.5 %) for an overall response rate of 65 %, 10 cases had stable disease (25 %) and 4 developed progressive disease (10 %).

The median duration of objective response was 10.5M (8-13M) with median survival of 15.5M (10-21M).

Hematologic toxicity of short duration was dose limiting with thrombocytopenia WHO grades 3 and 4 in 25 % and 20 % of patients respectively.

Neutropenia WHO grades 3 and 4 in 17.5 % and 5 % of patients, respectively.

Moreover 20 % of the patients showed grade 3 and 4 anemia.

Nausea & vomiting occurred mainly after cisplatin and were of grade 2 & 3in 20 % of the patients.

Flu like symptoms (including lethargy) grade 216 were recorded in 25 % of patients.

Conclusions : the GEM-CIS combination is a highly effective treatment for patients with locally advanced NSCLC with accepted level of toxicity and the 65 % overall objective response appears promising and suggests that GEM-CIS is one of the most active regimens so far studied.