Safety, Resource Use, and Quality of Life in Paramount: A Phase III Study of Maintenance Pemetrexed Versus Placebo after Induction Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

Gridelli, Cesare; Marinis, Filippo de; Pujol, Jean Louis; Reck, Martin; Ramlau, Rodryg; Parente, Bárbara; Pieters, Thierry; Middleton, Gary; Corral, J.; Winfree, Katherine B.; Melemed, Symantha; Zimmermann, Anna; John, William J.; Beyrer, Julie; Chouaki, N.; Visseren‐Grul, Carla; Paz‐Ares, Luis

doi:10.1097/jto.0b013e318267cf84

Cited by 48 publications

(38 citation statements)

References 22 publications

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“…For EQ-5D, the mean index score change from baseline ranged from 0.009 to 0.030, which is consistent with PARAMOUNT results (−0.02 to 0.01) [21]. For LCSS, the mean maximum improvements across items (0.4-24.5 mm VAS) were consistent with the JMEN study (1-11 mm VAS) [6].…”

Section: Discussionsupporting

confidence: 70%

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Feasibility of home delivery of pemetrexed in patients with advanced non-squamous non-small cell lung cancer

et al. 2015

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Section: Discussionsupporting

confidence: 70%

“…A larger proportion of patients (38%, 20 patients) discontinued due to TEAEs compared to PARAMOUNT (9.2%, 33 patients) [21]. Only 5 patients (10%) discontinued due to CTCAEs of Grade ≥3, which is similar to the overall discontinuation rate in PARAMOUNT, while the remainder (15 [28%]) discontinued due to CTCAEs of Grade 1/2.…”

Section: Discussionmentioning

confidence: 57%

Feasibility of home delivery of pemetrexed in patients with advanced non-squamous non-small cell lung cancer

et al. 2015

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“…Different chemotherapy regimens for advanced NSCLC may cause different distributions of toxicities. Gemcitabine/cisplatin regimen demonstrated more prominent thrombocytopenia, anemia, and renal toxicity, whereas pemetrexed-based regimen was more prone to inducing neutropenia, anemia, and fatigue [29,30]. Toxicities introduced by chemotherapeutic regimens should be considered when analyzing the toxicities of the combined therapies.…”

Section: Study or Subgroupmentioning

confidence: 99%

The protein kinase C (PKC) inhibitors combined with chemotherapy in the treatment of advanced non-small cell lung cancer: meta-analysis of randomized controlled trials

et al. 2014

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“…In addition, QoL was evaluated through the standardized EuroQol 5-dimensional scale (EQ-5D). These data demonstrated that patients can tolerate long-term use of continuation maintenance pemetrexed without worsening the QoL [10].…”

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confidence: 86%

The PARAMOUNT trial: Implications for Maintenance Therapy in Lung Cancer Patients

Rossi

2013

Lung Cancer Manage.

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The maintenance strategic approach has been extensively investigated in hematologic malignancies and then in solid tumors. Among thoracic cancers, small-cell lung cancer has been the setting for several clinical trials of maintenance treatment. The most recent systematic review pooled the available trials evaluating maintenance therapy in small-cell lung cancer, producing a thorough picture of efficacy related to different pharmacological strategies. Despite an overall survival (OS) advantage reported for maintenance chemo therapy and interferon treatment, the results are not clinically relevant [1,2,101]. Maintenance therapy has only recently been accepted as a treatment strategy for advanced non-smallcell lung cancer (NSCLC) with the main goal of prolonging a favorable clinical state after induction first-line platinum-based combination chemo therapy in respect of an adequate tolerability and without impairing quality of life (QoL). This renewed interest has been raised with the availability of active and tolerable new drugs. Among these, pemetrexed, a new cytotoxic agent, is a potent inhibitor of thymidylate synthase and other folate-dependent enzymes. Based on its mechanism of action, pemetrexed was the first chemotherapeutic to be studied as a targeted agent. In fact, due to the evidence of the differential expression of thymidylate synthase between adenocarcinoma and squamous NSCLC, pemetrexed reported an increased efficacy in nonsquamous histology, and thus it is now registered only for the treatment of this histotype worldwide [3,4]. With adequate vitamin supplementation, pemetrexed was shown to be active and well tolerated, with grade ≥3 toxicities, when administered as a single agent, not exceeding 5-10% [5].First, pemetrexed was tested as switch maintenance within the randomized Phase III trial JMEN. Advanced NSCLC patients of any histology not progressing after four cycles of platinum-based doublets, not including pemetrexed, were randomized to pemetrexed or placebo. Pemetrexed showed a statistically better progression-free survival (PFS) and OS than placebo, which were more significant for nonsquamous histology [6]. These results led to the design of the PARA-MOUNT study, a double-blind, multicenter, Phase III, randomized, placebocontrolled trial. The primary end point was PFS, chosen because this measure is not

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Safety, Resource Use, and Quality of Life in Paramount: A Phase III Study of Maintenance Pemetrexed Versus Placebo after Induction Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

Abstract: Long-term use of continuation maintenance pemetrexed was well tolerated; resource use was low, corresponding with known pemetrexed toxicities. The EQ-5D results demonstrate that patients tolerate long-term maintenance pemetrexed without worsening QoL.

Cited by 48 publications

References 22 publications

Feasibility of home delivery of pemetrexed in patients with advanced non-squamous non-small cell lung cancer

Feasibility of home delivery of pemetrexed in patients with advanced non-squamous non-small cell lung cancer

The protein kinase C (PKC) inhibitors combined with chemotherapy in the treatment of advanced non-small cell lung cancer: meta-analysis of randomized controlled trials

The PARAMOUNT trial: Implications for Maintenance Therapy in Lung Cancer Patients

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