Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Ciardiello, Fortunato; Normanno, Nicola; Martinelli, Erika; Troiani, Teresa; Pisconti, Salvatore; Cardone, Claudia; Nappi, Antonio; Bordonaro, A.R.; Rachiglio, Anna Maria; Lambiase, Matilde; Latiano, T.; Modoni, G.; Cordio, S.; Giuliani, Francesco; Biglietto, M.; Montesarchio, Vincenzo; Barone, Carlo; Tonini, Giuseppe; Cinieri, Saverio; Febbraro, Antonio; Rizzi, Daniele; Vita, Ferdinando De; Orditura, Michele; Colucci, Giuseppe; Maiello, Evaristo; Iaffaioli, Vincenzo Rosario; Nasti, Guglielmo; Botti, Gerardo; Tatangelo, Fabiana; Chicchinelli, Nicoletta; Montrone, Michele; Sebastio, Annamaria; Guarino, Tiziana; Simone, G.; Graziano, Paolo; Chiarazzo, Cinzia; Maggio, G. Di; Longhitano, Laura; Manusia, M; Cartenì, Giacomo; Nappi, Oscar; Micheli, Pietro; Leo, Luigi; Rossi, Sabrina; Cassano, Alessandra; Tommaselli, Eugenio; Giordano, Guido; Sponziello, F.; Marino, Antonella; Rinaldi, Antonio; Romito, S.; Muda, Andrea Onetti; Lorusso, Vito; Leo, Silvana; Barni, Sandro; Grimaldi, Giuseppe; Aieta, Michele

doi:10.1093/annonc/mdw136

Cited by 75 publications

(55 citation statements)

References 22 publications

(36 reference statements)

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“…The process of the literature selection and reasons for study exclusion are shown in Figure . We identified 3906 potentially relevant records through electronic search and 18 RCTs were ultimately included in this review after removal of duplicate publications and ineligible studies.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Sun

et al. 2019

J Evidence Based Medicine

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Objectives To investigate the efficacy and safety of adding anti‐epidermal growth factor receptor [EGFR] MoAbs to various chemotherapy regimens in patients with RAS wild‐type metastasized colorectal cancer (RAS WT metastatic colorectal cancer [mCRC]) and to identify the optimal combination regimens. Methods We searched MEDLINE, EMBASE, and CENTRAL from the inception date to 20th May 2019. Randomized clinical trials investigating chemotherapy with or without anti‐EGFR MoAbs in treatment of patients with RAS WT mCRC were included. Results Eighteen studies involving 8848 participants were eligible. Comparing with oxaliplatin‐based chemotherapy, adding anti‐EGFR MoAbs benefited only in progression‐free survival (PFS) (hazard ratio [HR] = 0.80, 95% confidence interval [CI]: 0.67 to 0.94), but not in overall survival (OS) (HR = 0.89, 95% CI: 0.78 to 1.02). Further sensitivity analysis indicated that adding anti‐EGFR MoAbs to FOLFOLX regimen as a first‐line treatment showed benefits in both PFS and OS (PFS: HR = 0.74, 95% CI: 0.64 to 0.84; OS: HR = 0.83, 95% CI: 0.73 to 0.95, respectively). Comparing with irinotecan‐based chemotherapy or best supportive care, adding anti‐EGFR MoAbs revealed an improvement in both PFS (HR = 0.77, 95% CI: 0.69 to 0.86; HR = 0.46, 95% CI: 0.40 to 0.54, respectively) and OS (HR = 0.89, 95% CI: 0.80 to 0.98; HR = 0.65, 95% CI: 0.54 to 0.78, respectively). Conclusion Anti‐EGFR MoAbs as a monotherapy or in combination with either irinotecan‐based chemotherapy or FOLFOX in patients with RAS wild‐type mCRC have better response and survival outcome, whereas OS does not benefit from adding anti‐EGFR MoAbs to another oxaliplatin‐based regimen. Anti‐EGFR MoAbs have increased the risk of adverse effects than chemotherapy alone. More high‐quality randomized controlled trials for RAS wild type are necessary.

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Section: Resultsmentioning

confidence: 99%

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Sun

et al. 2019

J Evidence Based Medicine

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“…Earlier studies have also found prolonged mOS when continuing bevacizumab beyond progression [29] . Further, in a study with cetuximab, a prolonged mPFS and a trend for a prolonged mOS have been found by continuing cetuximab beyond progression [30] . Therefore, it might be the continuing of antibodies beyond progression and not the combination of the 2 antibodies that resulted in the long mPFS and mOS found in the present study.…”

Section: Discussionmentioning

confidence: 92%

Dual Inhibition of EGFR and VEGF in Heavily Pretreated Patients with Metastatic Colorectal Cancer

Larsen

Markussen²,

Nielsen³

et al. 2017

Oncology

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Objective: The aim of this study was to evaluate the efficacy and safety of combining irinotecan, bevacizumab, and cetuximab/panitumumab as a 4th-line treatment in patients with metastatic colorectal cancer. Methods: All patients had KRAS wild-type metastatic colorectal cancer and had previously received fluoropyrimidine, oxaliplatin, irinotecan, and cetuximab/panitumumab in a 1st, 2nd, and 3rd line setting. Most patients had previously received bevacizumab as well. All patients had progressed within 3 months after the last given treatment before starting the triple combination therapy every second week. Results: Sixty-three patients were evaluated. The triple combination therapy was well tolerated. The median progression-free survival was 6.1 months, and the median overall survival was 11.9 months. Four patients (6%) obtained a partial response, and 40 (63%) had stable disease. Conclusion: The combination of irinotecan, bevacizumab, and cetuximab/panitumumab is safe and shows a toxicity profile corresponding to what is expected from the agents alone. The results indicate that the combination in the 4th line may result in a high rate of disease control in heavily pretreated patients with metastatic colorectal cancer.

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“…Standard regimens containing uorouracil, oxaliplatin, irinotecan, and targeted agents interfering with the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) pathways are widely used in the rst-line and second-line treatment for mCRC [5][6][7] . However, few drugs except regorafenib and TAS-102 were approved in the mCRC third-line settings by Food and Drug Administration (FDA) [19,20] .…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of fruquintinib for metastatic colorectal cancer third-line treatment in China

Peng

Hou

Huang

et al. 2020

Preprint

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Abstract Background: In this study, we analyze the cost-effectiveness of fruquintinib as third-line treatment for patients with metastatic colorectal cancer in China, especially after a recent price drop suggested by the National Healthcare Security Administration. Methods: A Markov model was developed to investigate the cost-effectiveness of fruquintinib compared to placebo among patients with metastatic colorectal cancer. Effectiveness was measured in quality-adjusted life years (QALY). The Chinese healthcare payer’s perspective was considered with a lifetime horizon, including direct medical cost (2019 US dollars [USD]). A willing‐to‐pay threshold was set at USD 27,130/QALY, which is three times the gross domestic product (GDP) per capita. We examined the robustness of the model in one-way and probabilistic sensitivity analysis.Results: Fruquintinib was associated with better health outcomes than placebo (0.640 vs 0.478 QALYs) with a higher cost (USD 20750.9 vs USD 12042.2), resulting in an incremental cost-effectiveness ratio (ICER) of USD 53508.7 per QALY. This ICER is 25% lower than the one calculated before the price drop (USD 70952.6 per QALY).Conclusion: After the price negotiation, the drug becomes cheaper and the ICER is lower, but the drug is still not cost effective under the standard of 3 times GDP willing‐to‐pay threshold. For patients with metastatic colorectal cancer in China, fruquintinib is not a cost-effective option under the current circumstances in China.

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Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Abstract: Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials.

Cited by 75 publications

References 22 publications

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Dual Inhibition of EGFR and VEGF in Heavily Pretreated Patients with Metastatic Colorectal Cancer

Cost-effectiveness analysis of fruquintinib for metastatic colorectal cancer third-line treatment in China

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