Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial

Galetta, Domenico; Cinieri, Saverio; Pisconti, Salvatore; Gebbia, Vittorio; Morabito, Alessandro; Borsellino, Nicola; Maiello, Evaristo; Febbraro, Antonio; Catino, Annamaria; Rizzo, P.; Montrone, Michele; Misino, A.; Logroscino, Antonio; Rizzi, Daniele; Maïo, Massimo Di; Colucci, Giuseppe

doi:10.1016/j.cllc.2014.12.002

Cited by 55 publications

(53 citation statements)

References 19 publications

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“…Because PEM-based therapy is an indispensable part of standard chemotherapy [15,23], failure to start the regimen can have a negative impact on patient outcomes. Our procedure enables earlier administration of standard chemotherapy, potentially avoiding problems associated with rapid disease progression before the initiation of chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

A Prospective Study of Shortened Vitamin Supplementation Prior to Cisplatin–Pemetrexed Therapy for Non-Small Cell Lung Cancer

et al. 2014

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Background. Prior supplementation with folic acid and vitamin B 12 is required to reduce pemetrexed therapy toxicity; the recommended lead-in time is at least 7 days. On the basis of previous pharmacokinetic and clinical studies, we hypothesized that the lead-in time could be shortened to 24 hours, enabling earlier commencement of standard chemotherapy; thus, we planned the first prospective trial of this regimen. Methods. Patients with advanced nonsquamous non-small cell lung cancer who had not previously received cytotoxic chemotherapy were enrolled. After measurement of homocysteine concentrations, the patients received 1,000 mg of vitamin B 12 by intramuscular injection and began taking 350-500 mg of oral folic acid daily. Starting 24-48 hours after the vitamin B 12 injection, the patients received intravenous 500 mg/m 2 pemetrexed and 75 mg/m 2 cisplatin for 4 cycles at 3

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Section: Discussionmentioning

confidence: 99%

A Prospective Study of Shortened Vitamin Supplementation Prior to Cisplatin–Pemetrexed Therapy for Non-Small Cell Lung Cancer

et al. 2014

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“…Bevacizumab combined with carboplatin plus paclitaxel has been directly compared with pemetrexed continuation maintenance in two Phase III studies (Table 6). 17,18 These two studies, PRONOUNCE and ERACLE, defined unique primary endpoints of PFS without grade 4 adverse events18 and difference in QoL,17 respectively, instead of the usual efficacy parameters of PFS or OS. Thus, these studies provided little information with regard to deciding which regimen is superior as the first-line regimen for patients with non-squamous NSCLC.…”

Section: Efficacy Safety and Tolerability Of Pemetrexed Maintenancementioning

confidence: 99%

Pemetrexed in maintenance treatment of advanced non-squamous non-small-cell lung cancer

Minami¹,

Kijima²

2015

LCTT

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Pemetrexed, a multitargeting antifolate cytotoxic drug, plays a leading role in front-line chemotherapy for patients with advanced non-squamous non-small-cell lung cancer (NSCLC). Following its approval as second-line monotherapy for locally advanced or metastatic non-squamous NSCLC, pemetrexed has established itself as the first-line regimen in combination with cisplatin, and its powerful antitumor effects and less cumulative toxicities were then taken advantage of in the JMEN and PARAMOUNT trials, respectively, to pioneer a new treatment strategy of switch and continuation maintenance monotherapy. These developments have brought about a marked paradigm shift, and made pemetrexed indispensable in the treatment for non-squamous NSCLC. So far, only three drugs have been approved for maintenance therapy; pemetrexed both by switch and continuation maintenance, erlotinib by switch maintenance, and bevacizumab by continuation maintenance. Compared with observation alone after defined cycles of the first-line chemotherapy, subsequent pemetrexed maintenance therapy has provided significantly longer survival and infrequent severe adverse events. The cost-effectiveness of pemetrexed maintenance therapy is controversial, as well as the other two maintenance drugs, bevacizumab and erlotinib. The latest attractive attention is a combination maintenance therapy. We may have to consider epidermal growth factor receptor (EGFR) mutation status for selection of a combination pattern. A combination maintenance therapy of pemetrexed plus bevacizumab is potential for patients with wild-type EGFR status, while a EGFR tyrosine kinase inhibitor-containing combination is promising for patients with active EGFR mutation status. Pemetrexed will be a pivotal drug when a combination maintenance therapy is used in practice. For future maintenance therapy, we need to explore reliable predictive selection or exclusion markers that can predict who will really benefit from maintenance therapy.

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“…A number of clinical studies on bevacizumab have been performed, and some demonstrated that the addition of bevacizumab to chemotherapy in the first-line setting significantly increased the progression-free survival (PFS), overall survival (OS) and RR of patients diagnosed with advanced lung cancer (4)(5)(6)(7)(8)(9)(10). However, there have been few studies on their feasibility or efficacy of bevacizumab in nonSq-NSCLC patients who were previously treated with a platinum-based regimen.…”

Section: Introductionmentioning

confidence: 99%

A feasibility study of bevacizumab and vinorelbine in patients with previously treated advanced non-squamous non-small-cell lung cancer

Kaburaki

Isobe

Kobayashi

et al. 2017

Molecular and Clinical Oncology

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Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial

Cited by 55 publications

References 19 publications

A Prospective Study of Shortened Vitamin Supplementation Prior to Cisplatin–Pemetrexed Therapy for Non-Small Cell Lung Cancer

A Prospective Study of Shortened Vitamin Supplementation Prior to Cisplatin–Pemetrexed Therapy for Non-Small Cell Lung Cancer

Pemetrexed in maintenance treatment of advanced non-squamous non-small-cell lung cancer

A feasibility study of bevacizumab and vinorelbine in patients with previously treated advanced non-squamous non-small-cell lung cancer

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