Pemetrexed and carboplatin, an active option in first-line treatment of elderly patients with advanced non-small cell lung cancer (NSCLC): A phase II trial

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 80; no. 2; pp. 185 - 190
• Main Authors: Gervais, Radj, Robinet, Gilles, Clément-Duchêne, Christelle, Denis, Fabrice, Kouri, Claude El, Martin, Philippe, Chouaki, Nadia, Bourayou, Nawel, Morère, Jean-François
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ireland Ltd 01-05-2013; Elsevier
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Carboplatin; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Disease-Free Survival; Drug-Related Side Effects and Adverse Reactions - chemically induced; Elderly; Female; First-line; Glutamates - administration & dosage; Glutamates - adverse effects; Guanine - administration & dosage; Guanine - adverse effects; Guanine - analogs & derivatives; Hematology, Oncology and Palliative Medicine; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Neoplasm Staging; Non-small cell lung cancer; Pemetrexed; Pneumology; Pulmonary/Respiratory; Stage IIIB-IV; Treatment Outcome; Tumors; Tumors of the respiratory system and mediastinum; Stage IIIB-IV; Carboplatin; First-line; Elderly; Pemetrexed; Non-small cell lung cancer; Human; Antineoplastic agent; Lung disease; Respiratory disease; Patient; Malignant tumor; non-small cell lung carcinoma; Treatment; Phase II trial; Bronchus disease; Advanced stage; Cancer; Non small cell carcinoma
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2013.01.008

Abstract The synergistic activity of pemetrexed with platinum agents in non-small cell lung cancer (NSCLC) and the renal safety of carboplatin suggest a balanced benefit/risk profile for this combination in elderly patients. This multicenter, single-arm, phase II study included 62 patients (≥70 years) with chemonaïve advanced NSCLC, Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1, and assigned to receive 6 cycles of 3-weekly pemetrexed 500 mg/m2 and carboplatin AUC 5. The primary endpoint was objective tumor response rate (ORR). Sixty-two patients received at least one dose of chemotherapy. Median age was 76.4 years [70.2–86] and all patients had PS 0 (16.1%) or PS 1 (83.9%). Stage IIIb disease in 21% patients and stage IV in 79% patients. Non-squamous cell carcinoma in 66.1% patients (adenocarcinoma 51.6%, large cell carcinoma 8.1%, other 6.5%) and squamous cell carcinoma in 33.9% patients. ORR was 28.6% (95% confidence interval [CI], 16.58–43.26), all were partial responses. Stable disease rate was 42.9%. Grade 3/4 toxicities related to study drugs were: asthenia 16.1%, anorexia 4.8%, diarrhea 3.2%, neutropenia 51.6%, leucopenia 30.7%, thrombocytopenia 29%, anemia 19.4%. One related fatal septic shock occurred. In advanced NSCLC, pemetrexed use is restricted to non-squamous histology. The combination pemetrexed-carboplatin could be a valuable treatment option in elderly patients. Neutropenia was the most common toxicity. The ORR is within the range of data reported for pemetrexed-carboplatin in the general NSCLC population (24–31%).