Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

Barlési, Fabrice; Scherpereel, Arnaud; Rittmeyer, Achim; Pazzola, Antonio; Tur, Neus Ferrer; Kim, Joo Hang; Ahn, Myung Ju; Aerts, Joachim; Gorbunova, Vera; Vikström, Anders; Wong, Elaine K.; Pérez-Moreno, Pablo; Mitchell, Lada; Groen, Harry J.M.

doi:10.1200/jco.2012.42.3749

Cited by 283 publications

(185 citation statements)

References 25 publications

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“…Some notable differences between the PARAMOUNT and JMDB populations were the NSCLC stage percentages (stage IIIB NSCLC: 9% versus 21%, respectively), "Other or indeterminate histology" (approximately 6% versus 17%, respectively), and smoking status "Unknown" (1% versus 35%, respectively). In general, the distribution of patient and disease characteristics represented in these three groups is similar to that seen in other recent phase III studies [7], [12], [13] and [14]. Percentages not totaling 100% are due to rounding or missing data.…”

Section: Resultssupporting

confidence: 80%

Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials

et al. 2014

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Highlights•Compared advanced NSCLC phase III trials: pemetrexed-cisplatin with or without pem maintenance.•4 cycles pem-cis followed by pem maintenance improves survival over 6 cycles pem-cis.•Longer exposure to pem-cis or maintenance pem increases some toxicities, but overall incidence low. Abstract ObjectivesTwo phase III trials of advanced NSCLC patients were compared to examine relative efficacy and safety of differing treatment regimens. The JMDB trial investigated first-line pemetrexed-cisplatin (pemetrexed 500 mg/m 2 plus cisplatin 75 mg/m 2 every 21 days; maximum: 6 cycles). The PARAMOUNT phase III trial compared maintenance pemetrexed versus placebo after patients with nonsquamous NSCLC completed 4 cycles of first-line pemetrexed-cisplatin without disease progression. MethodsOverall survival (OS) and progression-free survival (PFS), analyzed by Kaplan-Meier and Cox methods, and toxicity rates were compared between the PARAMOUNT arms and a selected homogeneous population from JMDB: 346 patients with disease and prior treatment characteristics matching the PARAMOUNT population. ResultsOutcomes for the PARAMOUNT placebo arm were similar to the JMDB homogeneous group (median PFS: 5.6 versus 6.2 months, p = 0.117, HR = 1.16; median OS: 14.0 versus 14.2 months, p = 0.979, HR = 1.00). The PARAMOUNT maintenance pemetrexed group had statistically superior efficacy compared with the JMDB homogeneous group (median PFS: 7.5 versus 6.2 months, p < 0.00001, HR = 0.66; median OS: 16.9 versus 14.2 months, p = 0.003, HR = 0.75). Patients who received pemetrexed maintenance (median 4 cycles, range 1-44) following 4 cycles of pemetrexed-cisplatin exhibited a higher incidence of drug-related serious adverse events compared with JMDB patients (median 6 cycles of pemetrexed-cisplatin) (10.6% versus 2.9%); grade 3/4 fatigue and renal toxicity were also higher in the pemetrexed arm of PARAMOUNT. ConclusionsThe across-trial comparison of a relevant JMDB study population with the two arms of the PARAMOUNT study supported the efficacy of the pemetrexed continuation maintenance strategy and suggested the results are not influenced by limiting the pemetrexed-cisplatin induction treatment to four cycles. Although longer exposure to pemetrexed-cisplatin or maintenance pemetrexed increased some toxicities, the overall incidence remained low, underscoring the relative safety of these treatment regimens.

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Section: Resultssupporting

confidence: 80%

Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials

et al. 2014

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“…W innym badaniu III fazy wykazano podobną skuteczność schematu z udziałem karboplatyny, pemetreksedu i bewacyzumabu (z podtrzymują-cym leczeniem pemetreksedem i bewacyzumabem) w porównaniu ze schematem zawierającym karboplatynę, paklitaksel i bewacyzumab (z podtrzymującym leczeniem bewacyzumabem) [140]. Z kolei w badaniu AVAPERL nie wykazano wyż-szości podtrzymującego leczenia z udziałem bewacyzumabu i pemetreksedu nad podtrzymującym leczeniem z udziałem wyłącznie bewacyzumabu u chorych na NDRP bez progresji po zastosowaniu chemioterapii z udziałem cisplatyny, pemetreksedu i bewacyzumabu [141].…”

Section: Inhibitory Angiogenezyunclassified

Rola systemowych metod leczenia u chorych na niedrobnokomórkowego raka płuca i złośliwego międzybłoniaka opłucnej: Uaktualnione zalecenia ekspertów

Jassem

Biernat

Bryl

et al. 2014

Advances in Respiratory Medicine

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Rak płuca jest w Polsce najczęstszą przyczyną zgonów nowotworowych. Około 85% wszystkich nowotworów płuca stanowi rak niedrobnokomórkowy (NDRP), w którym leki cytotoksyczne i ukierunkowane molekularnie odgrywają coraz większą rolę. W pracy przedstawiono oparte na obecnej wiedzy zalecenia dotyczące stosowania tych metod w praktyce klinicznej u chorych na NDRP oraz na złośliwego międzybłoniaka opłucnej.

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“…Nevertheless, it appears to us to be an interesting basis for selecting patients, especially in the firstline setting, as chemotherapy (which can be associated with bevacizumab and maintenance therapy) is associated with a response rate and a PFS that can reach 35% and 7.4 months [Barlesi et al 2013;Sandler et al 2006], respectively. Moreover, recent studies underlined the potential predictive factor of immune markers not only in the tumor cells but also in the surrounding immune cells.…”

Section: Anti-pd1 and Anti-pdl1 Antibodiesmentioning

confidence: 99%

Targeting the immune system to treat lung cancer: rationale and clinical experience

Guibert

Delaunay

2015

Ther Adv Respir Dis

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Abstract:The use of immunotherapy that harnesses and enhances the innate powers of the immune system to fight cancer cells represents the most promising new cancer treatment approach since the development of the first chemotherapies and, more recently, targeted therapies. Unexpectedly, lung cancer has recently emerged as an exciting new target for immune-based therapies. Several approaches to immunotherapy for lung cancer have shown promise in early clinical trials and in late-phase development. The most advanced strategies can be split into two main categories: therapeutic vaccines and checkpoint inhibitors. At this time of great expectations, this review provides the reader with an update on the immunotherapies used to treat lung cancer with a focus on the rationale of targeting the immune system. It reports the results from recent major clinical trials, describes new toxicity profiles associated with such drugs, and particularly the role of the pulmonologists in their management. This review provides an overview of the main perspectives within this field.

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Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

Cited by 283 publications

References 25 publications

Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials

Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials

Rola systemowych metod leczenia u chorych na niedrobnokomórkowego raka płuca i złośliwego międzybłoniaka opłucnej: Uaktualnione zalecenia ekspertów

Targeting the immune system to treat lung cancer: rationale and clinical experience

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