HSR20-095: Progression-Free Survival, Overall Survival, and Tumor Response for Patients Diagnosed With Small Cell Lung Cancer Who Received First-Line Systemic Therapy

PurposeTo evaluate the efficacy of cetuximab added to first-line gemcitabine/platinum in chemotherapy-naïve patients with advanced non–small-cell lung cancer (NSCLC).Patients and MethodsIn this noncomparative, randomized trial, chemotherapy-naïve patients with recurrent/metastatic NSCLC (stage IV or stage IIIB with malignant pleural effusion) were eligible. Patients received cisplatin (75 mg/m2IV, every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [IV], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m2IV, days 1 and 8) plus cetuximab (400 mg/m2IV day 1, followed by 250 mg/m2weekly), in arm A, or chemotherapy alone, in arm B. Response rate was the primary end point; safety, progression-free survival, and overall survival were secondary end points.ResultsSixty-five patients were randomly assigned to arm A and 66 to arm B. Partial responses were observed in 18 patients (27.7%; 95% CI, 17.3 to 40.2) in arm A and 12 (18.2%; 95% CI, 9.8 to 29.6) in arm B. Median progression-free survival was 5.09 months for arm A (95% CI, 4.17 to 5.98) and 4.21 months (95% CI, 3.81 to 5.49) in arm B. Median overall survival was 11.99 months (95% CI, 8.80 to 15.18) and 9.26 months (95% CI, 7.43 to 11.79) in arms A and B, respectively. Overall toxicity was acceptable and consistent with the profiles of the individual agents.ConclusionFirst-line treatment with cetuximab plus gemcitabine/platinum is well tolerated and can be administered safely in patients with advanced NSCLC. Differences in response rate, progression-free survival, and overall survival suggest that the addition of cetuximab to platinum/gemcitabine may improve clinical outcomes. Larger studies are in progress to address this hypothesis.

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Prediction of overall survival or progression free survival by disease control rate at week 8 is independent of ethnicity: Western versus Chinese patients with first-line non-small cell lung cancer treated with chemotherapy with or without bevacizumab

The Journal of Clinical Pharmacology ◽

10.1002/jcph.191 ◽

2013 ◽

Vol 54 (3) ◽

pp. 253-257 ◽

Cited By ~ 7

Author(s):

Laurent Claret ◽

Manish Gupta ◽

Kelong Han ◽

Amita Joshi ◽

Nenad Sarapa ◽

...

Keyword(s):

Lung Cancer ◽

Overall Survival ◽

Small Cell Lung Cancer ◽

Disease Control ◽

Progression Free Survival ◽

Small Cell ◽

Chinese Patients ◽

Small Cell Lung ◽

First Line ◽

Free Survival

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Afatinib in the first-line treatment of patients with non-small cell lung cancer: clinical evidence and experience

Therapeutic Advances in Respiratory Disease ◽

10.1177/1753466618808659 ◽

2018 ◽

Vol 12 ◽

pp. 175346661880865 ◽

Cited By ~ 5

Author(s):

Biagio Ricciuti ◽

Sara Baglivo ◽

Andrea De Giglio ◽

Rita Chiari

Keyword(s):

Lung Cancer ◽

Overall Survival ◽

Small Cell Lung Cancer ◽

Clinical Evidence ◽

Progression Free Survival ◽

Small Cell ◽

Small Cell Lung ◽

First Line ◽

Free Survival ◽

Egfr Mutant

Epidermal growth factor receptor ( EGFR) gene mutations identify a molecularly defined subset of non-small cell lung cancer (NSCLC) patients who display an excellent sensitivity to EGFR tyrosine kinase inhibitors (TKIs). First-generation reversible EGFR TKIs, gefitinib and erlotinib have been proven to improve the objective response rate and to prolong the progression-free survival compared with standard chemotherapy in large phase III trials. Unfortunately, virtually all patients develop resistance to treatment, usually within 9–12 months. Afatinib is an irreversible ErbB family inhibitor initially designed to overcome the development of resistance. Compared with gefitinib in a first-line setting, afatinib prolonged progression-free survival and time to treatment failure, without impacting on overall survival in the general population of EGFR-mutant patients. However, afatinib has been shown to prolong overall survival in the subset of patients with an EGFR exon 19 deletion compared with chemotherapy. The aim of this review is to summarize the clinical evidence available to date and to critically discuss the place in therapy of afatinib in the rapidly expanding landscape of EGFR-mutant NSCLC first-line therapy.

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