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 Printable version |
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 |
Bulletin du Cancer. Volume 91, Number 9, 10273-7, Septembre 2004, Electronic journal of oncology
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 Free Article
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Author(s) : Tommaso De Pas MD, Giuseppe Curigliano MD, Giulia Veronesi, Gianpiero Catalano MD, Chiara Catania MD, Barbara Jereczek‐Fossa MD, Roberto Orecchia MD, Lorenzo Spaggiari MD, Filippo de Braud MD |
Summary :
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. |
Keywords : Pre‐operative chemotherapy, radiotherapy, NSCLC |
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