Anti-PD-1 and regorafenib induce severe multisystem adverse events in microsatellite stability metastatic colorectal cancer: a case report

Immunotherapy ◽  
2021 ◽  
Author(s):  
Yuchen Yang ◽  
Lingyan Xu ◽  
Danping Wang ◽  
Bingqing Hui ◽  
Xiaofei Li ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Case Report ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Tumor Shrinkage ◽  
Line Treatment ◽  
Third Line ◽  
Grade 3 ◽  
Microsatellite Stability ◽  
Third Line Treatment

There exists a dilemma in the treatment of microsatellite stability (MSS) metastatic colorectal cancer (mCRC) owing to limited therapeutic options. Based on the promising results of the REGONIVO trial, combination of anti-PD-1 and regorafenib could be applicable for this kind of patients. Here we first report a case of an MSS mCRC patient who received sinitilimab plus regorafenib as third-line treatment and suffered severe multisystem treatment-related adverse events including Grade 3 myocarditis, myositis, myasthenia gravis, dermatitis, hepatitis, etc. Fortunately, all these adverse events have been reversed with administration of corticosteroids. Though evidence of tumor shrinkage was not found, CEA levels markedly decreased. Therefore, anti-PD-1 plus regorafenib might be optional for the MSS mCRC patients which requires special caution in the clinical practice.

A phase II study of apatinib combined with S-1 in previously treated refractory metastatic colorectal cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15016-e15016
Author(s):  
Ning Li ◽  
Wenying Deng ◽  
Guifang Zhang ◽  
Yanwei Guo ◽  
Yijie Ma ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Survival Time ◽  
Response Rate ◽  
Phase Ii Study ◽  
Line Treatment ◽  
Third Line ◽  
Grade 3 ◽  
Third Line Treatment

e15016 Background: Although regorafenib and fruquintinib have been recommended as the third-line treatment for patients with refractory metastatic colorectal cancer (mCRC), the median survival time of mCRC is still only for 4-8 months and the low response rate and unpleasant side effects limit their use in Chinese patients. Apatinib, an oral VEGFR-2 inhibitor, has been approved as a third line treatment in metastatic gastric cancer. In addition, apatinib has demonstrated good safety, tolerability, and efficacy in the treatment of advanced solid tumors. The aim of this study was to assess the efficacy and safety of apatinib combined with S-1 in the treatment of refractory mCRC. Methods: In this prospective, open-label, single-arm, multicenter, phase II study, patients after failure of second-line chemotherapy were enrolled and took apatinib (250mg, daily) combined with S-1 (standard dose). The primary endpoint was progression free survival (PFS) and the second endpoint was response rate and overall survival time. Results: From December 2017, 22 patients (14 male) with a median age of 56y (range: 34-71 y) were enrolled and eligible for evaluation of the PFS, response rate and safety. The median PFS was 105d (95% CI: 79.01-130.98). two patients (9%) achieved partial response, 15 (68.18%) achieved stable disease, and 5 (22.72%) were progressive disease. The objective response rate and the disease control rate were 9% and 77.27%, respectively. Median overall survival was not reached. The common adverse effects were abnormal liver function (7/22; 31.81%), leukopenia (5/22; 22.72%) and thrombocytopenia (4/22; 18.18%). The incidence for grade 3-4 side effect was very low. One patient experienced grade 3 proteinuria and there were no toxic deaths. Conclusions: This preliminary result indicated that apatinib combined with S-1 may extend the PFS in mCRC, with well-tolerated toxicities, making it a promising therapeutic target for mCRC treatment. Clinical trial information: NCT03397199 .

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

2020 ◽  
Author(s):  
Zhi Peng ◽  
Xingduo Hou ◽  
Yangmu Huang ◽  
Tong Xie ◽  
Xinyang Hua
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Metastatic Colorectal Cancer ◽  
Cost Effective ◽  
Line Treatment ◽  
Lifetime Horizon ◽  
Life Years ◽  
Third Line ◽  
The Cost ◽  
Third Line Treatment

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.

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

2020 ◽  
Author(s):  
Zhi Peng ◽  
Xingduo Hou ◽  
Yangmu Huang ◽  
Tong Xie ◽  
Xinyang Hua
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Metastatic Colorectal Cancer ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Line Treatment ◽  
Lifetime Horizon ◽  
Third Line ◽  
The Cost ◽  
Third Line Treatment

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 year (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 USD 27,130/QALY, which is 3 times 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 an incremental results 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.

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

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhi Peng ◽  
Xingduo Hou ◽  
Yangmu Huang ◽  
Tong Xie ◽  
Xinyang Hua
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Metastatic Colorectal Cancer ◽  
Cost Effective ◽  
Line Treatment ◽  
Lifetime Horizon ◽  
Life Years ◽  
Third Line ◽  
The Cost ◽  
Third Line Treatment

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.

Cost-effectiveness analysis of cetuximab as third-line treatment in metastatic colorectal cancer

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 15090-15090
Author(s):  
M. Romeo ◽  
G. Soler ◽  
M. Martínez Villacampa ◽  
B. Laquente ◽  
A. López Doriga ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Metastatic Colorectal Cancer ◽  
Cost Effectiveness Analysis ◽  
Line Treatment ◽  
Effectiveness Analysis ◽  
Third Line ◽  
Third Line Treatment

Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer: A multicenter United Kingdom study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 668-668
Author(s):  
Chara Stavraka ◽  
Athanasios Pouptsis ◽  
Paul Kabuubi ◽  
Vasileios Angelis ◽  
Alicja Synowiec ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
Duration Of Treatment ◽  
Third Line ◽  
The Uk ◽  
Third Line Treatment

668 Background: TAS-102 is an orally administered combination of the thymidine-based nucleic acid analogue, trifluridine and the thymidine phosphorylase inhibitor, tipiracil hydrochloride. Following the phase III RECOURSE study, it received approval as third line treatment for metastatic colorectal cancer showing significant improvement in overall and progression free survival and an acceptable toxicity profile. Methods: We performed a multicenter retrospective observational study of patients with metastatic colorectal cancer receiving TAS-102 as third line treatment between 2016 and 2018 in Cancer centers across the UK. Results: A total of 143 patients were included (94 men, 49 women). Median age was 68 years (35-82). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 90% of patients had ECOG ≥ 1. Median duration of treatment was 2.9 months (0.5-22.9), with a response rate of 1.6% and stable disease achieved in 24%. Median OS was 7 months (95% CI 5.84-8.15) and median PFS 2.6 months (95% CI 2.2-3.36). A dose reduction was required in 28% of patients, while 8% discontinued treatment due to toxicity. AEs reported included fatigue 81.3% (G3 16.8%), nausea 34.5% (G3 4.5%) and diarrhoea 25.5% (G3 1.8%). Neutropenia was common 50.4%, (≥ G3: 25.4%) with 4.2% cases of neutropenic fever while thrombocytopenia was less frequent 8.7% (≥ G3 1.8%). Conclusions: The OS, PFS and ORR observed in our real-world experience were consistent with the RECOURSE trial, though we noted a lower disease control rate. Overall, TAS-102 was well tolerated and the most prevalent adverse events seen in our patients were in keeping with those reported in the trial. Although severe toxicities were less frequent than the trial, we experienced higher rates of toxicity induced dose reductions and treatment cessations, which could reflect the differences between trial and real world populations. Further validation is warranted.

Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study

2020 ◽  
Vol 26 (1) ◽  
pp. 111-117
Author(s):  
Yoichiro Yoshida ◽  
◽  
Takeshi Yamada ◽  
Hirohiko Kamiyama ◽  
Chihiro Kosugi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Line Treatment ◽  
Third Line ◽  
Third Line Treatment
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