Final overall results of a study with a novel triplet induction chemotherapy regimen (PACCAGE) followed by consolidation radiotherapy in locally advanced inoperable non-small cell lung cancer (NSCLC).

Introduction: We report the long term and overall results of a triplet induction chemotherapy regimen followed by standard radiotherapy in patients with locally advanced inoperable stage III non-small cell lung cancer.

Methods: Three cycles of paclitaxel, carboplatin, and gemcitabine were administered every 3 weeks before standard fractionated consolidation radiotherapy starting at least 4 weeks after the last chemotherapy administration. Toxicity and antitumor response was assessed in detail as well as the progression free and overall survival.

Results: Sixty-four patients (25 stage IIIA and 39 stage IIIB) received a total of 179 cycles of chemotherapy. Fifty-six received the planned three cycles. Full-dose radiotherapy was administered in 47 patients (73%), a reduced dose in 11 (17%) and none in six (10%). A 55% objective response rate (OR) (one complete and 34 partial responses) was observed after induction chemotherapy. After completing the whole treatment including radiotherapy, the OR was 40 of 47 evaluable patients (85%). Median time to progression was 10.9 month and median overall survival was 17.2 month, with a significant difference between stage IIIA and stage IIIB patients (23.4 versus 10.5 month; p = 0.011). The strongest predictor for a favorable long-term outcome was a metabolic complete response after chemotherapy.

Conclusion: Induction chemotherapy with the paclitaxel, carboplatin, and gemcitabine regimen preceding radiotherapy in patients with locally advanced inoperable stage III non-small cell lung cancer was feasible and active. Radiotherapy could be administered at a full dose in the majority of patients with acceptable toxicity. Long-term survival results of this sequential chemoradiotherapy regimen appear similar to those of concurrent treatment. Patients not achieving a metabolic complete response after induction chemotherapy should be the focus of studies aiming at improved local control.