Multicenter phase II study on cisplatin, pemetrexed, and bevacizumab followed by maintenance with pemetrexed and bevacizumab for patients with advanced or recurrent nonsquamous non-small cell lung cancer: MAP study

Tsutani, Yasuhiro; Miyata, Yoshihiro; Masuda, Takeshi; Fujitaka, Kazunori; Doi, Mihoko; Awaya, Yoshikazu; Kuyama, Shoichi; Kitaguchi, Souichi; Ueda, Kazuhiro; Hattori, Noboru; Okada, Morihito

doi:10.1186/s12885-018-5146-3

Cited by 12 publications

(11 citation statements)

References 23 publications

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“…Many clinical trials of anti-VEGF drugs have shown that patients receiving anti-VEGF drugs had higher rates of GI perforation than those without such treatment [ [21] , [22] , [23] , [24] , [25] ]. Several authors have further reported that the risk of emergency surgery due to anti-VEGF agent-related severe adverse effects in advanced cancer was estimated to be as high as 2.8% [ 23 , [26] , [27] , [28] , [29] ]. Other authors reported that the fatality rate of patients with GI perforation treated with anti-VEGF drugs was as high as 20% [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy. Case series

Maeda

Shinohara

Minagawa

et al. 2020

Annals of Medicine and Surgery

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Background Treatment for acute abdomen during chemotherapy is frequently difficult because of the complicated status of the patients, and there have been only a few case series summarizing the outcomes of emergent surgery during chemotherapy. The aim of this study was to clarify the clinical outcomes of emergency surgery for acute abdomen during chemotherapy and identify predictive factors associated with mortality. Methods We retrospectively analyzed the records of patients who underwent emergency surgery for acute abdomen within 30-days after anti-cancer drugs administration between 2009 and 2020. Results Thirty patients were identified. The primary malignancies were hematological (n = 7), colorectal (n = 4), lung (n = 4), stomach (n = 2), breast (n = 2), prostate (n = 2) and others (n = 5). Fifteen patients were treated with the regimen, including molecular-targeted anti-cancer drugs (Bevacizumab: 8 cases, Rituximab: 4, Ramucirumab: 2, and Gefitinib: 1). Indications for emergency surgery were perforation of the gastrointestinal tract (n = 24), appendicitis (n = 3), bowel obstruction (n = 2), and gallbladder perforation (n = 1). Severe morbidity (Clavien-Dindo IIIa or more) occurred in 8 cases (27%), and there were 6 in-hospital deaths (20%). Significant factors related to in-hospital death were age >70 years old (P = 0.029), poor performance status (ECOG score 1 or 2) (P = 0.0088), and serum albumin level <2.6 g/dl (P = 0.026). The incidence of acute abdomen (odds ratio 5.31, P = 0.00017) was significantly higher in the patients receiving anti-VEGF drugs than in those without anti-VEGF drugs. Conclusion This study identified three predictive factors associated with in-hospital death after emergency surgery during chemotherapy: an older age, poor performance status, and low serum albumin level.

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Section: Discussionmentioning

confidence: 99%

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy. Case series

Maeda

Shinohara

Minagawa

et al. 2020

Annals of Medicine and Surgery

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“…Thus, the expected mPFS of 7.5 months was not reached in this study. Nevertheless, anlotinib plus chemotherapy induced fewer TRAEs, especially grade 3–4 TRAEs, compared with bevacizumab plus chemotherapy 18 …”

Section: Discussionmentioning

confidence: 94%

“…The mPFS of platinum plus pemetrexed was 4.5 months, as mentioned above, and combining anlotinib with platinum and pemetrexed showed an improved mPFS of 5.75 months in this study. Bevacizumab plus platinum and pemetrexed were reported to achieve even better mPFS (7.4–10.8 months), 17 , 18 and the use of pemetrexed in the maintenance treatment might be an explanation. In this study, only anlotinib was used in the maintenance treatment.…”

Section: Discussionmentioning

confidence: 98%

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Anlotinib plus chemotherapy for T790M‐negative EGFR‐mutant non‐sqNSCLC resistant to TKIs: A multicenter phase 1b/2 trial

Tian

Zheng

et al. 2022

Thoracic Cancer

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Background This multicenter phase 1b/2 trial aimed to explore the maximum tolerated dose (MTD), activity, and safety of anlotinib plus chemotherapy in patients with T790M‐negative epidermal growth factor receptor ( EGFR )‐mutant advanced nonsquamous non‐small cell lung cancer (NSCLC) after resistance to first‐ or second‐generation EGFR tyrosine kinase inhibitors (TKIs). Methods In the phase 1b stage, patients received anlotinib (8/10/12 mg, days 1–14) combined with cisplatin (75 mg/m 2 , day 1) or carboplatin (AUC = 5, day 1) plus pemetrexed (500 mg/m 2 , day 1) for a 3‐week cycle based on a 3 + 3 dose‐escalation design. In the phase 2 single‐arm stage, anlotinib was administered at MTD combined with platinum plus pemetrexed for four cycles, followed by anlotinib maintenance therapy. The primary endpoint of the phase 2 stage was progression‐free survival (PFS). Results The study was prematurely terminated due to slow accrual after 19 patients had been enrolled between January 18, 2019, and March 21, 2021. The MTD of anlotinib was 12 mg. The median PFS was 5.75 (95% confidence interval, 4.37–7.52) months. The objective response rate was 47.4% (95% confidence interval, 24.5%–71.1%). In the 12 mg group, seven (58.3%) patients experienced grade 3–4 treatment‐related adverse events, and the most common ones were hypertension (6 [50.0%]), decreased platelet count (2 [16.7%]), and hypertriglyceridemia (1 [8.3%]). No treatment‐related deaths occurred. Conclusion Anlotinib plus platinum and pemetrexed showed promising antitumor activity with manageable toxicity in patients with T790M‐negative EGFR ‐mutant advanced nonsquamous NSCLC after progression on first‐ or second‐generation EGFR TKIs.

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“…In the JMDB study, PC was the preferred chemotherapy regimen for non-small cell lung cancer ( Scagliotti et al, 2008 ). Moreover, many studies demonstrated that the combination of bevacizumab with PC was well tolerated in the treatment of NSCLC ( Barlesi et al, 2013 ; Patel et al, 2013 ; Zinner et al, 2015 ; Xu et al, 2016 ; Shan et al, 2018 ; Tsutani et al, 2018 ; Kreis et al, 2019 ). We conducted the assessment of treatment with real world study to compare the efficacy and safety of low (7.5 mg/kg) and high (15 mg/kg) dose of bevacizumab in combination with PC in advanced non-squamous NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Different Doses of Bevacizumab Combined With Pemetrexed and Platinum in First-Line Treatment of Advanced NSCLC: A Retrospective-Real World Study

et al. 2021

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Background: Bevacizumab was demonstrated to have efficacy in patients with NSCLC. However, application of different doses of bevacizumab in different clinical trials was overlooked. This study aims to investigate the effects and safety of different doses of bevacizumab in the treatment.Methods: From January 2016 to March 2020, 79 patients with NSCLC received first-line combination treatment with chemotherapy (pemetrexed + platinum) and bevacizumab for four cycles; patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab combined with pemetrexed, of which 57 patients received bevacizumab at a dose of 7.5 mg/kg and 22 patients at a dose of 15 mg/kg. The primary endpoint was progression-free survival, and secondary endpoints were overall response rate, disease control rate, and adverse events.Results: There was no significant difference between two groups in effectiveness; Median PFS in 7.5 mg/kg group and in 15 mg/kg group were 8.0 and 8.7 months, respectively (p = 0.663), reaching the primary endpoint. The ORR and DCR in the bevacizumab 7.5 and 15 mg/kg group were 45.46 and 86.0% vs. 50 and 90.9% showing no statistical significance (p = 0.804 and 0.717). Most of side effects were tolerable. The incidences of overall toxicities were higher in 15 mg/kg group (p = 0.001). No new safety signals were observed.Conclusion: We did not detect significant difference of efficacy and safety between 7.5 mg/kg group and 15 mg/kg group for bevacizumab administration, the cost-effectiveness of the 7.5 mg/kg group was significantly better than that of the 15 mg/kg group.

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Multicenter phase II study on cisplatin, pemetrexed, and bevacizumab followed by maintenance with pemetrexed and bevacizumab for patients with advanced or recurrent nonsquamous non-small cell lung cancer: MAP study

Cited by 12 publications

References 23 publications

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy. Case series

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy. Case series

Anlotinib plus chemotherapy for T790M‐negative EGFR‐mutant non‐sqNSCLC resistant to TKIs: A multicenter phase 1b/2 trial

Efficacy and Safety of Different Doses of Bevacizumab Combined With Pemetrexed and Platinum in First-Line Treatment of Advanced NSCLC: A Retrospective-Real World Study

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