Survival Benefit of Crossover Administration of Regorafenib and Trifluridine/Tipiracil Hydrochloride for Patients With Metastatic Colorectal Cancer: Exploratory Analysis of a Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study (REGOTAS)

Chida, Keigo; Kotani, Daisuke; Moriwaki, Toshikazu; Fukuoka, Shota; Masuishi, Toshiki; Takashima, Atsuo; Kumekawa, Yosuke; Kajiwara, Takeshi; Yamazaki, Kentaro; Komoda, Masato; Makiyama, Akitaka; Denda, Tadamichi; Hatachi, Yukimasa; Suto, Takeshi; Sugimoto, Naotoshi; Enomoto, Masanobu; Ishikawa, Toshiaki; Kashiwada, Tomomi; Ando, Koji; Yuki, Satoshi; Okita, Yoshihiro; Kusaba, Hitoshi; Sakai, Daisuke; Okamoto, Koichi; Tamura, Takao; Yamashita, Kimihiro; Gosho, Masahiko; Shimada, Yasuhiro

doi:10.3389/fonc.2021.576036

Cited by 5 publications

(4 citation statements)

References 20 publications

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“…The period of this study differed from that of the CORRECT study, and the increase in TFTD use was thought to have extended the survival post-progression and ultimately prolonged the OS in our study. Using fluoropyrimidine, oxaliplatin, and irinotecan is known to prolong survival 19 , but currently, it has been recognised that using up both regorafenib and TFTD in the salvage line is important for prolonging OS 20,21 .…”

Section: Laboratory Abnormalitiesmentioning

confidence: 99%

Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer

Kato

Kudo

Kagawa

et al. 2023

Sci Rep

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Regorafenib has shown significant survival benefit as a salvage therapy for colorectal cancer; however, its starting dose has been controversial in recent studies. Therefore, we conducted a prospective study on the efficacy and safety of the dose reduction of regorafenib to 120 mg. Patients received 120 mg regorafenib once per day for 3 weeks, followed by a 1-week off-treatment period. The primary endpoint was the investigator-assessed disease control rate (DCR). Sixty patients were registered, and the DCR was 38.3% with a median progression-free survival of 2.5 months (95% confidence interval [CI] 1.9–3.7) and median overall survival of 10.0 months (95% CI 6.9–15.2). Common grade 3–4 adverse events were hand-foot skin reaction and hypertension (20.0% each). The results of administration of 120 mg regorafenib as the starting dose are consistent with reports from prior phase III trials, which used starting doses of 160 mg. This lower initiating dose of regorafenib may be beneficial to certain patient populations. This clinical trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR number UMIN000018968, registration date: 10/09/2015).

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Section: Laboratory Abnormalitiesmentioning

confidence: 99%

Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer

Kato

Kudo

Kagawa

et al. 2023

Sci Rep

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“…The 3 references retrieved by citation were excluded because they were all from the same clinical trial and did not report detailed data on outcome indicators. Finally, 8 studies (14,30,31,(34)(35)(36)(37)(38) with a total of 1,287 patients were included in the metaanalysis (Table 1). The NOS scores of the included studies were all ≥7 (Table 2), indicating that the quality of the studies was good.…”

Section: Literature Search Results and Quality Evaluationmentioning

confidence: 99%

The prognostic role of neutrophil-to-lymphocyte ratio and C-reactive protein in metastatic colorectal cancer using regorafenib: a systematic review and meta-analysis

Zhao¹,

Xu²,

Zhou³

et al. 2022

J Gastrointest Oncol

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Background: The application of regorafenib has changed the landscape of subsequent-line treatment in metastatic colorectal cancer (mCRC). Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP), as two of the most common inflammatory factors, are suggested to be potential prognostic factors for mCRC patients treated with regorafenib, but the results are conflicting. In this study, we conducted a metaanalysis to evaluate the prognostic role of NLR and CRP in mCRC patients treated with regorafenib. Methods:We searched online databases such as Embase, PubMed, and the Cochrane library up to April 2022, without language limitation, to identify clinical studies evaluating the prognostic role of NLR or CRP in regorafenib treated mCRC patients. The main endpoints were hazard ratio (HR) of overall survival (OS) and progression-free survival (PFS). The associations between NLR, CRP, and the above endpoints were extracted. Review Manager 5.4 was used to conduct the combined analysis. The Newcastle-Ottawa Scale (NOS) was applied for assessing the quality of included studies. Heterogeneity was detected by chi-squarebased Q test and I 2 statistic, and publication bias was evaluated by funnel plot asymmetry and Egger's test.Results: Eight studies involving 1,287 cases were included, with 5 reporting survival outcomes based on NLR level and 4 reporting survival according to CRP level. The results of meta-analysis showed that the calculated HR of OS for subsequent-line regorafenib in mCRC patients with high versus low NLR was 2.52 [I 2 =52%, 95% confidence interval (CI): 1.75-3.64; P<0.00001]. The combined HR of PFS with high versus low baseline NLR was 2.11 (I 2 =12%, 95% CI: 1.80-2.48; P<0.00001). For patients with a high level of CRP, the OS was significantly shorter when compared with patients with a low level of CRP (I 2 =0%, HR =1.88; 95% CI: 1.55-2.29; P<0.00001).Conclusions: High level of NLR could be associated with OS in mCRC patients treated with regorafenib.It is suggested that the impact of regorafenib on OS may vary according to the baseline NLR.

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“…Chida et al. recruited 550 mCRC patients and revealed prolonged survival in patients treated with both REG and TAS-102, as compared with either REG or TAS-102 alone ( 16 ). Unseld et al.…”

Section: Discussionmentioning

confidence: 99%

An Observational Study of Trifluridine/Tipiracil-Containing Regimen Versus Regorafenib-Containing Regimen in Patients With Metastatic Colorectal Cancer

et al. 2022

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BackgroundThere are no randomized control trials comparing the efficacy of trifluridine/tipiracil and regorafenib in patients with metastatic colorectal cancer (mCRC). Herein, we conducted an observational study to compare the oncologic outcomes of trifluridine/tipiracil-containing regimen (TAS-102) and regorafenib-containing regimen (REG) in patients with mCRC.Material and methodPatients who were diagnosed to have mCRC in 2015 to 2021 and treated with TAS-102-containing regimen or REG-containing regimen were recruited. Monotherapy or combination therapy were all allowed in this study. Oncologic outcomes were presented with progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and disease control rate (DCR).ResultsA total of 125 patients were enrolled into our study, accounting for 50 patients with TAS-102 and 75 patients with REG. Of these patients, 64% were treated with TAS-102 or REG monotherapy, while the remaining were treated with TAS-102 combination or REG combination. In general, the median PFS and OS were 3.7 versus 2.0 months (P = 0.006) and 9.2 versus 6.8 months (P = 0.048) in TAS-102 and REG, respectively. The ORR and DCR were 44% versus 20% (P < 0.001) and 72% versus 43% (P < 0.001) in TAS-102 and REG, respectively. As for treatment strategies, the survival were significantly longer in combination than in monotherapy, no matter in TAS-102 or REG group. Multivariate analysis showed TAS-102 and combination therapy were independent predictor associated with better survival.ConclusionsOur results suggested that TAS-102 had better oncologic outcomes than REG in patients with mCRC, especially in combination. Further prospective trials are warranted to confirm our results.

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Survival Benefit of Crossover Administration of Regorafenib and Trifluridine/Tipiracil Hydrochloride for Patients With Metastatic Colorectal Cancer: Exploratory Analysis of a Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study (REGOTAS)

Cited by 5 publications

References 20 publications

Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer

Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer

The prognostic role of neutrophil-to-lymphocyte ratio and C-reactive protein in metastatic colorectal cancer using regorafenib: a systematic review and meta-analysis

An Observational Study of Trifluridine/Tipiracil-Containing Regimen Versus Regorafenib-Containing Regimen in Patients With Metastatic Colorectal Cancer

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