Unknown

Dataset Information

0

Phase II selection design trial of concurrent chemotherapy and cetuximab versus chemotherapy followed by cetuximab in advanced-stage non-small-cell lung cancer: Southwest Oncology Group study S0342.


ABSTRACT:

Purpose

Randomized clinical trials failed to show a survival benefit for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors plus concurrent chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC), with preclinical data suggesting potential negative interactions. In contrast, pilot trials of the EGFR-targeted antibody, cetuximab, plus chemotherapy suggested enhanced antitumor activity. This randomized phase II trial was designed to select a cetuximab plus chemotherapy regimen for phase III evaluation.

Patients and methods

Treatment-naive patients with advanced-stage NSCLC were randomly assigned to receive paclitaxel (225 mg/m(2)) and carboplatin (area under the curve, 6) every 3 weeks plus concurrent cetuximab (400 mg/m(2) loading dose followed by 250 mg/m(2) weekly) for four cycles followed by maintenance cetuximab or sequential paclitaxel-carboplatin for four cycles followed by cetuximab.

Results

Of 242 patients enrolled, 224 were eligible and assessable for response (106 and 118 patients in the concurrent and sequential arms, respectively). With a median follow-up time of 32 months, the median overall survival was 10.9 months (95% CI, 9.2 to 13.0 months) for patients receiving concurrent therapy and 10.7 months (95% CI, 8.5 to 12.8 months) for patients receiving sequential therapy (P = .57); 1-year survival rates were 45% (95% CI, 36% to 54%) and 44% (95% CI, 35% to 53%), respectively. Response rates and progression-free survival times were similar in both arms, as was grade 3 rash, whereas sensory neuropathy was higher in the concurrent arm (15% v 5% in the sequential arm; P = .036).

Conclusion

Although both regimens met the efficacy criterion for continued evaluation, the concurrent regimen of paclitaxel/carboplatin plus cetuximab was chosen.

SUBMITTER: Herbst RS 

PROVIDER: S-EPMC3020704 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

altmetric image

Publications

Phase II selection design trial of concurrent chemotherapy and cetuximab versus chemotherapy followed by cetuximab in advanced-stage non-small-cell lung cancer: Southwest Oncology Group study S0342.

Herbst Roy S RS   Kelly Karen K   Chansky Kari K   Mack Philip C PC   Franklin Wilbur A WA   Hirsch Fred R FR   Atkins James N JN   Dakhil Shaker R SR   Albain Kathy S KS   Kim Edward S ES   Redman Mary M   Crowley John J JJ   Gandara David R DR  

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20101004 31


<h4>Purpose</h4>Randomized clinical trials failed to show a survival benefit for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors plus concurrent chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC), with preclinical data suggesting potential negative interactions. In contrast, pilot trials of the EGFR-targeted antibody, cetuximab, plus chemotherapy suggested enhanced antitumor activity. This randomized phase II trial was designed to select a cetuximab pl  ...[more]

Similar Datasets

| S-EPMC5870479 | biostudies-literature
| S-EPMC8980080 | biostudies-literature
| S-EPMC6127191 | biostudies-literature
| S-EPMC2917315 | biostudies-literature
| S-EPMC3018361 | biostudies-literature
| S-EPMC6491187 | biostudies-literature
| S-EPMC11764324 | biostudies-literature
| S-EPMC2928397 | biostudies-literature
| S-EPMC3049578 | biostudies-literature
| S-EPMC8009170 | biostudies-literature