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A randomised phase II study of pemetrexed versus pemetrexed plus erlotinib as second-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer
Kaiser Franz Josef Spital, Austria Kaiser Franz Josef Spital, Austria .
St George Hospital Fejer County, Hungary .
Hospital Clin Barcelona, Spain .
Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine.
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2014 (English)In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 50, no 9, 1571-1580 p.Article in journal (Refereed) Published
Abstract [en]

Introduction: Pemetrexed and erlotinib have been approved as second-line monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC). This multicentre, randomised, open-label, parallel phase II study assessed efficacy and safety of pemetrexed versus pemetrexed + erlotinib in patients with advanced non-squamous NSCLC. Methods: NSCLC stage III-IV patients who failed one prior platinum-based chemotherapy regimen, greater than= 1 measurable lesion by Response Evaluation Criteria in Solid Tumors, and Eastern Cooperative Oncology Group performance status less than= 2 were eligible. Patients received pemetrexed 500 mg/m(2) with vitamin B-12 and folic acid q3w alone or combined with erlotinib 150 mg daily. The primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), time-to-treatment failure (TTTF), response and toxicity. Results: Of 165 randomised non-squamous patients, 159 were treated (pemetrexed: 83; pemetrexed + erlotinib: 76). The median PFS (months; 95% CI) was 2.89 (1.94, 3.38) for pemetrexed versus 3.19 (2.86, 4.70) for pemetrexed + erlotinib (hazard ratio [HR] 0.63; 95% CI: (0.44, 0.90); P = 0.0047). The median OS (months; 95% CI) was 7.75 (5.29, 10.41) for pemetrexed versus 11.83 (8.18, 16.66) for pemetrexed + erlotinib (HR: 0.68; 95% CI: 0.46, 0.98; P = 0.019). The median TTTF (months: 95% CI) was 2.4 (1.74, 2.99) for pemetrexed versus 3.0 (2.23, 4.07) for pemetrexed + erlotinib (HR 0.64; 95% CI: 0.46, 0.89; P = 0.0034). One patient died in pemetrexed + erlotinib arm due to febrile neutropenia. Grades 3/4 drug-related toxicities (in greater than= 5% of patients) in pemetrexed/pemetrexed + erlotinib were febrile neutropenia (2.4%/10.5%), diarrhoea (1.2%/5.3%), rash (1.2%/9.2%); anaemia (6%/11.8%), leukopenia (9.6%/23.7%), neutropenia (9.6%/25.0%), and thrombocytopenia (4.8%/14.5%). Conclusions: Pemetrexed + erlotinib treatment significantly improved PFS, OS and TTTF in 2nd line non-squamous NSCLC and was associated with an increase in grade 3/4 toxicities compared with pemetrexed alone.

Place, publisher, year, edition, pages
Elsevier , 2014. Vol. 50, no 9, 1571-1580 p.
Keyword [en]
Non-small cell lung cancer; Non-squamous; Second-line therapy; Pemetrexed; Erlotinib
National Category
Clinical Medicine
URN: urn:nbn:se:liu:diva-107827DOI: 10.1016/j.ejca.2014.03.007ISI: 000336372900001OAI: diva2:727935
Available from: 2014-06-23 Created: 2014-06-23 Last updated: 2015-03-31

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Sederholm, Christer
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Division of Cardiovascular MedicineFaculty of Health SciencesDepartment of Respiratory Medicine
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