Phase II study of pemetrexed as first-line treatment in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group Trial 0901

Kim, Young Hak; Hirabayashi, Masataka; Kosaka, Shinji; Nikaidoh, J.; Yamamoto, Yasumichi; Shimada, Muneaki; Toyazaki, Toshiya; Nagai, Hiroki; Sakamori, Yuichi; Mishima, Michiaki

doi:10.1007/s00280-013-2142-9

Cited by 13 publications

(12 citation statements)

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“…Detailed toxicity data were not available for all patients because of the retrospective nature of the study, and were, therefore, not considered in our analysis. However, treatment with pemetrexed in elderly patients with MPM was generally feasible, confirming previous data in MPM and other cancers (Ceresoli et al , 2008; Gridelli et al , 2012; Gervais et al , 2013; Kim et al , 2013). …”

Section: Discussionsupporting

confidence: 86%

Prognostic factors in elderly patients with malignant pleural mesothelioma: results of a multicenter survey

et al. 2014

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Background:The incidence of malignant pleural mesothelioma (MPM) in elderly patients is increasing. There are no specific guidelines for their management.Methods:The clinical records of elderly patients (⩾70 years old) with MPM referred from January 2005 to November 2011 to six Italian Centres were reviewed. Age, gender, histology, International Mesothelioma Interest Group (IMIG) stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), Charlson Comorbidity Index (CCI) and treatment modalities were analysed and correlated to overall survival (OS).Results:In total, 241 patients were identified. Charlson Comorbidity Index was ⩾1 in 92 patients (38%). Treatment was multimodality therapy including surgery in 18, chemotherapy alone in 180 (75%) and best supportive care in 43 cases (18%). Chemotherapy was mainly pemetrexed based. Median OS was 11.4 months. Non-epithelioid histology (HR 2.32; 95% CI 1.66–3.23, P<0.001), age ⩾75 years (HR 1.44; 95% CI 1.08–1.93, P=0.014), advanced (III–IV) stage (HR 1.47; 95% CI 1.09–1.98, P=0.011) and CCI⩾1 (HR 1.38; 95% CI 1.02–1.85, P=0.034) were associated to a shorter OS. Treatment with pemetrexed was associated with improved OS (HR 0.40; 95% CI 0.28–0.56, P<0.001).Conclusions:Non-epithelioid histology, age ⩾75 years, advanced IMIG stage and presence of comorbidities according to CCI were significant prognostic factors in elderly patients with MPM. Treatment with pemetrexed-based chemotherapy was feasible in this setting. Prospective dedicated trials in MPM elderly patients selected according to prognostic factors including comorbidity scales are warranted.

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Section: Discussionsupporting

confidence: 86%

Prognostic factors in elderly patients with malignant pleural mesothelioma: results of a multicenter survey

et al. 2014

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“…A meta‐analysis of 2671 patients with NSqNSCLC and good PS revealed that the effect of pemetrexed on overall survival did not differ between younger and older patients when cut‐off ages of 65 or 70 years were used . Moreover, in elderly patients aged ≥ 75, pemetrexed was reported to be safe and effective . Pemetrexed is very effective and causes little toxicity in patients with NSqNSCLC, even in elderly populations .…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, in elderly patients aged ≥ 75, pemetrexed was reported to be safe and effective . Pemetrexed is very effective and causes little toxicity in patients with NSqNSCLC, even in elderly populations . However, there is a lack of information about the optimal treatments for elderly patients with locally advanced NSqNSCLC.…”

Section: Discussionmentioning

confidence: 99%

“…In elderly patients (i.e. those aged ≥75 years) with previously treated NSCLC, pemetrexed monotherapy provided equivalent efficacy to docetaxel monotherapy, which is the standard treatment regimen for elderly NSCLC patients; caused significantly fewer side effects; and was confirmed to be safe and especially effective against non‐squamous NSCLC (NSqNSCLC) …”

Section: Introductionmentioning

confidence: 99%

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Phase I study of pemetrexed and concurrent radiotherapy for previously untreated elderly patients with locally advanced non‐squamous non‐small cell lung cancer

et al. 2017

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BackgroundChemoradiotherapy is the standard treatment for locally advanced non‐small cell lung cancer (NSCLC); however, it is disputed whether this treatment is suitable for patients aged ≥75. This study was conducted to determine the maximum tolerated dose (MTD) of pemetrexed for use in concurrent radiotherapy for elderly patients with locally advanced non‐squamous NSCLC.MethodsThe eligibility criteria were as follows: aged ≥75 with inoperable stage IIIA or IIIB non‐squamous NSCLC, no history of chemotherapy or radiotherapy, a performance status of 0 or 1, and adequate organ function. The patients were scheduled to receive pemetrexed on days 1, 22, 43, and 64 with concurrent once daily thoracic radiotherapy (60 Gy). The initial pemetrexed dose was 400 (level 1), and it was planned to increase the dose to 500 mg/m2 (level 2).ResultsTwo patients were enrolled in this trial. In the first case, the patient suffered prolonged leukocytopenia, and treatment was discontinued on day 35. In the second case, febrile neutropenia occurred on day 32, and the patient developed drug‐induced pneumonitis and acute respiratory distress syndrome. Both patients experienced dose‐limiting toxicities; therefore, the level 1 dose was considered to be the MTD.ConclusionsDuring combined treatment with pemetrexed and concurrent radiotherapy, a pemetrexed dose of 400 mg/m2 was the MTD; we did not set up a phase II study. Concurrent chemoradiotherapy might be too toxic for elderly patients aged ≥75 with locally advanced NSCLC.

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“…Gridelli et al [17] put forward that the median PFS and OS for elderly patients with stage IIIB/IV NSCLC are 4.5 months and 3.3 months, respectively. Kim et al [18] have found that median PFS and OS of elderly NS-NSCLC patients who received pemetrexed as first-line treatment are 3.3 and 17.5 months, respectively. In the present study, OS, PFS, and DCR of all patients receiving pemetrexed-based treatment in first-line setting was 15.6 months, 4.5 months, and 67.3%, separately, supporting favorable antitumor activity of pemetrexed-based treatment in elderly patients.…”

Section: Discussionmentioning

confidence: 99%

Single pemetrexed is noninferior to platinum-based pemetrexed doublet as first-line treatment on elderly Chinese patients with advanced nonsquamous nonsmall cell lung cancer

et al. 2017

Medicine

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Background:To evaluate the clinical efficacy and toxicity of single pemetrexed treatment compared with platinum-based pemetrexed doublet pemetrexed-based as first-line treatment for advanced nonsquamous nonsmall cell lung cancer (NS-NSCLC) in elderly Chinese patients.Methods:The study retrospectively reviewed 175 elderly Chinese patients with NS-NSCLC from June 2010 to September 2013: 90 patients received single pemetrexed treatment, 45 received pemetrexed plus oxaliplatin, and 40 received pemetrexed plus carboplatin. Clinical efficacy was assessed using disease control rate (DCR), overall survival (OS), and progression-free survival (PFS).Results:DCR, OS, and PFS did not significantly differ between single pemetrexed treatment (OS: 14.9 months; DCR: 62.2%; PFS: 3.3 months), pemetrexed plus oxaliplatin (OS: 16.5 months; DCR: 71.1%; PFS: 4.5 months), and pemetrexed plus carboplatin (OS: 15.5 months; DCR: 70.0%; PFS: 4.6 months) groups. Pemetrexed treatment caused significantly lower incidences of adverse events, such as hepatotoxicity and peripheral nerve injury. Performance status (PS), TNM stage, and Thymidylate synthase (TS) expression were predictive factors of DCR. Pemetrexed chemotherapy cycles, PS, and TNM stage were independent prognostic factors.Conclusions:Single pemetrexed was noninferior to platinum-based pemetrexed doublet for clinical efficacy and safety in elderly Chinese patients with advanced NS-NSCLC. Chemotherapy cycles, performance status, and TNM stage were independent prognostic factors.

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Phase II study of pemetrexed as first-line treatment in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group Trial 0901

Abstract: Although this study did not meet our primary endpoint, pemetrexed showed favorable antitumor activity with mild toxicity in elderly patients with non-squamous NSCLC. Further investigations of pemetrexed in this population are warranted (UMIN-CTR number, 000002452).

Cited by 13 publications

References 24 publications

Prognostic factors in elderly patients with malignant pleural mesothelioma: results of a multicenter survey

Prognostic factors in elderly patients with malignant pleural mesothelioma: results of a multicenter survey

Phase I study of pemetrexed and concurrent radiotherapy for previously untreated elderly patients with locally advanced non‐squamous non‐small cell lung cancer

Single pemetrexed is noninferior to platinum-based pemetrexed doublet as first-line treatment on elderly Chinese patients with advanced nonsquamous nonsmall cell lung cancer

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