Blanco R et al. - Long-term results are encouraging for concurrent chemoradiotherapy (CCR) following induction chemotherapy with cisplatin and gemcitabine in non-small cell lung cancer (NSCLC); however, nonhematologic toxicity of chemoradiation is substantial Methods
Prospective, multicentric, phase II trial of efficacy and toxicity of CCR after induction chemotherapy with cisplatin and gemcitabine
Review of pts with unresectable stage III NSCLC, no pleural effusion, adequate pulmonary, renal, liver and hematologic functions, Karnofsky index >70 and planned treated volume (PTV) <2200 cm3
Treatment: 3 cycles of cisplatin (100 mg/m2, day 1) and gemcitabine (1250 mg/m2, days 1 and 8) every 3 wks, followed by CCR (gemcitabine 50 mg/m2 on Mondays and Thursdays and radiotherapy 68.4 Gy, 1.8 Gy qd)
Cisplatin dose reduced to 70 mg/m2 and gemcitabine to 35 mg/m2 during CCR due to unacceptable toxicity after in 22 pts (grp A)
Inclusion of additional 33 eligible pts (grp B)
Treatment discontinuation during induction in 5 grp A pts and 6 grp B pts, thus CCR initiated in 17 grp A and 27 grp B pts
Nonhematologic grades III–IV toxicity of chemoradiation: significant and similar in grps A vs B (esophagitis 35.2% vs 33.3%; pneumonitis 23.5% vs 25.9%)
Treatment completion: 40.9% in grp A vs 57.5% in grp B
Overall response (intention-to-treat analysis): 68.1%, grp A; 63.5% grp B
Median survival: 17.7 mo for whole group (20% of pts alive at 3 yrs); mean follow-up: 41.2 mo
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