John Libbey Eurotext

Bulletin du Cancer

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Optimization of the schedule of gemcitabine‐cisplatin combination as induction regimen for patients with biopsy‐proven stage IIIa N2 – stage IIIb non‐small‐cell lung cancer: a prospective phase‐II study Volume 91, numéro 9, Septembre 2004

Auteurs
Department of Medical Oncology, Division of Thoracic Surgery and Radiotherapy, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy

Aim of this study was to define the optimal schedule of gemcitabine (GCB)\cisplatin (CDDP) combination as induction chemotherapy (CHT) in patients with stage IIIa pN2‐IIIb non – small‐cell lung cancer (NSCLC). Fifty patients with mediastinoscopically‐proven stage‐IIIa pN2 ‐IIIb NSCLC were treated with 3 cycles of induction CHT followed by surgery (if staged IIIa) and three‐time‐daily accelerated radiotherapy. Chemotherapy initially consisted of 3 courses of CDDP 100 mg\m 2 d1 plus GCB 1000 mg\m 2 dd 1,8,15 repeated every 4 weeks, than was modified in CDDP 80 mg\m 2 d1 plus GCB 1250 mg\m 2 dd 1,8 repeated every 3 weeks. Twenty‐nine four‐week scheduled treatment cycles were firstly administered to 10 patients (pts): treatment‐related toxicity, mainly hematological, caused a dose‐reduction or treatment omission on day 15 in 65% of cycles. After the protocol was amended, 119 three‐week scheduled treatment cycles were administered to 40 pts. Treatment‐related toxicity of the new schedule caused a dose‐reduction or treatment omission in only 10% of cycles, no patients requiring chemotherapy discontinuation. Thirty‐seven out of fifty patients (74%, 95% CI: 60‐85%) achieved a partial response, 7 had stable disease and 6 had disease progression. Similar activity was seen with both schedules. One nodal pathological complete remission was observed among the 24 pts who underwent surgery. At present, with a median follow‐up of 13 months (mos), 2‐year (y) survival of all the 50 pts and of the 24 pts staged IIIa who underwent surgery is estimated as 37% (95% CI: 24‐58%) and 47% (95%CI: 27‐80%), respectively. When given as induction chemotherapy, a three‐week schedule of CDDP plus GCB combination appeared to be effective, with lower toxicity and better compliance than a four‐week schedule.