Pemetrexed Therapy in Elderly Patients With Good Performance Status: Analysis of Two Phase III Trials of Patients With Nonsquamous Non–Small-Cell Lung Cancer

Gridelli, Cesare; Brodowicz, Thomas; Langer, Corey J.; Peterson, Patrick; Islam, Mominul; Guba, Susan C.; Moore, Patti; Visseren‐Grul, Carla; Scagliotti, Giorgio Vittorio

doi:10.1016/j.cllc.2011.12.002

Cited by 30 publications

(19 citation statements)

References 26 publications

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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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“…Subset analyses of pemetrexed registration trials showed that the benefit of pemetrexed is maintained in elderly advanced NSCLC patients without compromising tolerability [11, 12]. In elderly first-line NSCLC patients treated with pemetrexed + cisplatin, the rates of neutropenia, thrombocytopenia, and febrile neutropenia appeared to increase with age [11].…”

Section: Discussionmentioning

confidence: 99%

“…In elderly first-line NSCLC patients treated with pemetrexed + cisplatin, the rates of neutropenia, thrombocytopenia, and febrile neutropenia appeared to increase with age [11]. However, in all age groups, the <70-year age group, the ≥65-year age group, and ≥70-year age group in our trial, the rates of neutropenia (39.6, 38.2, 45.7, and 47.1 %, respectively), thrombocytopenia (14.2, 14.6, 14.3, and 11.8 %, respectively), and febrile neutropenia (0, 0, 0, and 0 %, respectively) were approximately the same in pemetrexed-treated patients.…”

Section: Discussionmentioning

confidence: 99%

Elderly Subset Analysis of Randomized Phase III Study Comparing Pemetrexed Plus Carboplatin with Docetaxel Plus Carboplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Pereira

Cheng²,

Orlando³

et al. 2013

Drugs R D

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BackgroundMany physicians consider platinum-doublet chemotherapy inappropriate for elderly patients, regardless of their medical fitness.ObjectiveThis was a retrospective subgroup analysis of data from a multicenter, randomized, phase III clinical trial evaluating pemetrexed + carboplatin versus docetaxel + carboplatin in elderly chemo-naive patients with advanced, nonsquamous non-small cell lung cancer (NSCLC).MethodsData from elderly patients (aged ≥65 years and ≥70 years) were evaluated using the same statistical methods as those used in patients aged <70 years and qualified intent-to-treat (Q-ITT) populations. The primary objective of the clinical trial was comparison of pemetrexed + carboplatin with docetaxel + carboplatin in terms of survival without grade 3 or 4 toxicity in chemo-naive NSCLC patients.ResultsThe ≥65- and ≥70-year age groups had 68 and 37 patients, respectively. Among patients aged ≥65 years, the adjusted hazard ratio (HR) for survival without grade 3–4 toxicity (HR 0.40, 95 % confidence interval [CI] 0.23–0.70) favored pemetrexed + carboplatin; this was similar to the HRs in patients aged ≥70 years (HR 0.43, 95 % CI 0.20–0.92), patients aged <70 years (HR 0.44, 95 % CI 0.32–0.62), and the Q-ITT population (HR 0.45, 95 % CI 0.34–0.61). The median values for overall survival (OS) and progression-free survival (PFS) were similar across all age-group subsets and the Q-ITT population. The HRs for OS and PFS were similar for all age-group subsets, except for the ≥70-year age group, which favored pemetrexed + carboplatin to a greater extent. The toxicity profile was similar across age groups, with the exception of diarrhea, mucosal inflammation, and grade 3–4 neutropenia and leukopenia, which were slightly more common in elderly patients in both treatment arms. Between-arm differences in the toxicity profiles for the ≥65-, ≥70- and <70-year age subgroups were similar to those in the Q-ITT population. There were no on-study deaths or unexpected toxicities.ConclusionThe benefits of pemetrexed + carboplatin were maintained, and toxicity was manageable in both elderly subgroups. The favorable risk–benefit profile of pemetrexed + carboplatin makes it an appropriate first-line treatment option for elderly patients with advanced nonsquamous NSCLC.

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“…Because of the toxicity of some chemotherapeutic agents, a widely held misperception contends that all elderly patients, even those with good performance status (performance status [PS] 0–1), are unable to tolerate aggressive chemotherapy. Gridelli et al analyzed two randomized studies to evaluate the survival and safety of treatment with pemetrexed in elderly patients (<65 years and ≥65 years, and <70 years and ≥70 years; all patients PS 0–1) with nonsquamous NSCLC 24. They found that for patients with first line therapy, the incidence of grade 3/4 toxicities related to pemetrexed plus cisplatin therapy relative to comparator-related toxicities in each of the four age groups were generally consistent with the results reported for all patients with nonsquamous NSCLC (neutropenia 15.1%, thrombocytopenia 4.1%, anemia 5.6%, fatigue 6.7%, and vomiting 6.1%).…”

Section: Introductionmentioning

confidence: 99%

Critical appraisal of pemetrexed in the treatment of NSCLC and metastatic pulmonary nodules

Li¹,

Wei²,

Chen³

2014

OTT

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Pemetrexed, a new multitarget antifolate antineoplastic agent, has significantly improved the overall survival in nonsquamous non-small-cell lung cancer patients. Presently, pemetrexed is recommended for first line treatment in combination with platinum derivatives, for second line treatment as a single agent and, more recently, as maintenance treatment after first line chemotherapy. In this article we critically appraise the status of pemetrexed including pharmacodynamics, pharmacokinetics, toxicity, and the cost effectiveness of pemetrexed, as well as the predictive biomarkers for pemetrexed based chemotherapy.

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Pemetrexed Therapy in Elderly Patients With Good Performance Status: Analysis of Two Phase III Trials of Patients With Nonsquamous Non–Small-Cell Lung Cancer

Cited by 30 publications

References 26 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

Elderly Subset Analysis of Randomized Phase III Study Comparing Pemetrexed Plus Carboplatin with Docetaxel Plus Carboplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Critical appraisal of pemetrexed in the treatment of NSCLC and metastatic pulmonary nodules

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