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A randomised phase ...
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
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- Dittrich, Christian (author)
- Kaiser Franz Josef Spital, Austria Kaiser Franz Josef Spital, Austria
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- Papai-Szekely, Zsolt (author)
- St George Hospital Fejer County, Hungary
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- Vinolas, Nuria (author)
- Hospital Clin Barcelona, Spain
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- Sederholm, Christer (author)
- Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för kardiovaskulär medicin,Hälsouniversitetet,Lungmedicinska kliniken US
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- Hartmann, Joerg T. (author)
- Department Internal Medical II Hematol and Medical Oncol, Germany Catholic Hospital Consortium Ostwestfalen, Germany
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- Behringer, Dirk (author)
- Clin Hematol and Oncol, Germany
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- Kazeem, Gbenga (author)
- Eli Lilly UK, England
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- Desaiah, Durisala (author)
- Eli Lilly Corp Centre, IN USA
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- Leschinger, Monika I. (author)
- Lilly Deutschland GmbH, Germany
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- von Pawel, Joachim (author)
- Asklepios Hospital Munchen Gauting, Germany
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(creator_code:org_t)
- Elsevier, 2014
- 2014
- English.
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In: European Journal of Cancer. - : Elsevier. - 0959-8049 .- 1879-0852. ; 50:9, s. 1571-1580
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- Non-small cell lung cancer; Non-squamous; Second-line therapy; Pemetrexed; Erlotinib
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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Dittrich, Christ ...
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Papai-Szekely, Z ...
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Vinolas, Nuria
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Sederholm, Chris ...
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Hartmann, Joerg ...
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Behringer, Dirk
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Kazeem, Gbenga
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Desaiah, Durisal ...
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Leschinger, Moni ...
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von Pawel, Joach ...
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Linköping University