scholarly journals Regorafenib-Induced Hand‐Foot Skin Reaction Is More Severe on the Feet Than on the Hands

2019 ◽  
Vol 27 (5) ◽  
pp. 551-556
Author(s):  
Yuma Nonomiya ◽  
Takashi Yokokawa ◽  
Kazuyoshi Kawakami ◽  
Kazuo Kobayashi ◽  
Takeshi Aoyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Risk Factors ◽  
Metastatic Colorectal Cancer ◽  
Skin Reaction ◽  
Common Side Effect ◽  
Correct Trial ◽  
Significant Difference ◽  
Hand Foot Skin Reaction ◽  
Grade 3 ◽  
Hands And Feet

Regorafenib is a multikinase inhibitor for the treatment of metastatic colorectal cancer. Regorafenib-induced hand‐foot skin reaction (HFSR) is a common side effect during treatment. The reported frequency of HFSR was 80% (grade 3: 28%) in the Japanese subpopulation in the CORRECT trial; however, more detailed data regarding HFSR in terms of onset and sites of susceptibility are unclear. Additionally, the risk factors for regorafenib-induced severe HFSR are unknown. The aim of this study was to compare HFSR between the hands and feet and identify preexisting risk factors for severe HFSR in Japanese patients receiving regorafenib. We retrospectively examined the onset and severity of HFSR on the hands and feet of patients with metastatic colorectal cancer treated with regorafenib from May 2013 to October 2015 in the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. In addition, we examined the possible association between preexisting clinical factors and severe HFSR. Our results showed that no significant difference in the incidence of HFSR of any grade was observed between the hands (71%) and feet (74%) (p = 0.63). The incidence of grade 3 HFSR was more frequent on the feet (33%) than on the hands (8%) (p < 0.01). The onset of grade 3 HFSR was earlier on the feet than on the hands (p < 0.001). No preexisting risk factor was identified. Our findings indicate that severe HFSR was more prevalent on the feet than on the hands, suggesting the need for appropriate screening for early detection and treatment of regorafenib-induced HSFR.

Genetic variants of genes in CCL5/CCR5 pathway to predict regorafenib-induced hand-foot skin reaction in patients with refractory metastatic colorectal cancer: A report of ethnic difference.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 615-615 ◽  
Author(s):  
Mitsukuni Suenaga ◽  
Marta Schirripa ◽  
Shu Cao ◽  
Wu Zhang ◽  
Dongyun Yang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Skin Reaction ◽  
Ethnic Difference ◽  
Japanese Patients ◽  
Candidate Snps ◽  
Training Cohort ◽  
Hand Foot Skin Reaction ◽  
Grade 3

615 Background: CCL5/CCR5 pathway is involved in VEGF-A production and a recent study reported that serum CCL5 levels predict onset of hand-foot skin reaction (HFSR) due to regorafenib. We therefore tested whether genetic polymorphisms in the CCL5/CCR5 pathway predict onset of HFSR in patients with refractory metastatic colorectal cancer (mCRC) receiving regorafenib. Methods: Two independent cohorts treated with regorafenib were included in this study: a training cohort from Japan with 79 patients (median age 62 years, male 47%); and a testing cohort from Italy with 150 patients (median age 62 years, male 54%). Single nucleotide polymorphisms (SNPs) of genes in CCL5/CCR5 pathway ( CCL5, CCR5, PRCKD, CCL3, CCL4, KLF13, HIF1A) were selected for analyses using PCR-based direct sequencing. Adverse events were graded according to the CTCAE version 4.0. Comparisons of variants’ and adverse events’ distributions across two cohorts, and association between SNPs and adverse events were analyzed using contingency tables and Fisher’s exact test. Results: Grade 3 ≤ HFSR was more frequent in Japanese patients compared with Italian patients (32.9% vs. 16.0%, P= 0.004). The frequency of homozygous variant in CCL5 SNPs varied between Japanese and Italian patients (G/G variant in rs2280789, 21.5% vs. 1.3%, P< 0.001; T/T variant in rs3817655, 22.8% vs. 2.7%, P< 0.001). In the training cohort, patients with the G/G variant in rs2280789 had a higher incidence of grade 3 ≤ HFSR compared to those with any A allele (53% vs. 27%, P= 0.078); and the T/T variant in rs3817655 was significantly associated with onset of grade 3 ≤ HFSR compare to any A allele (56% vs. 26%, P= 0.026). These findings were not confirmed in the testing cohort, and no significant differences for toxicities were observed in the other candidate SNPs. Conclusions: Germline CCL5 polymorphisms in the CCL5/CCR5 pathway may serve as predictor of onset of severe HFSR in refractory mCRC patients receiving regorafenib. The different percentage of homozygote of CCL5 SNPs confers the ethnic difference in developing severe HFSR between Italian and Japanese patients.

scholarly journals Prevention for Hand-Foot Skin Reaction with Regorafenib Monotherapy for Refractory Metastatic Colorectal Cancer

2014 ◽  
Vol 25 ◽  
pp. v107
Author(s):  
Yumiko Ohta ◽  
Shuntaro Yoshida ◽  
Hideki Fujita ◽  
Akiko Narita ◽  
Takayuki Shimpou ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Skin Reaction ◽  
Hand Foot Skin Reaction

Risk factors for gastrointestinal perforations in patients with metastatic colorectal cancer receiving bevacizumab plus chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3535-3535 ◽  
Author(s):  
M. Sugrue ◽  
M. Kozloff ◽  
J. Hainsworth ◽  
S. Badarinath ◽  
A. Cohn ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Risk Factors ◽  
Metastatic Colorectal Cancer ◽  
Potential Risk ◽  
Primary Tumor ◽  
Phase Iii ◽  
Community Based ◽  
Large Community ◽  
Significant Difference ◽  
Potential Risk Factors

3535 Background: Bevacizumab (BV) prolongs overall survival and progression-free survival when added to standard chemotherapy in patients (pts) with metastatic colorectal cancer (mCRC). BRiTE is a large, community-based observational registry of pts with mCRC receiving BV plus first-line chemotherapy (CT). Incidence rate, temporal pattern, and potential risk factors associated with gastrointestinal perforation (GIP) were explored. Methods: Baseline patient characteristics (BC), including prospectively identified potential risk factors for GIP, were collected at study entry. Safety data were collected every 3 months (mo). Logistic regression models, adjusted and unadjusted for treatment assignment, were used to identify BC potentially associated with GIP. Results: 1968 pts were enrolled between Feb 2004 and Jun 2005. Median study follow-up was 10 mo as of Nov 4, 2005. GIPs were observed in 34 pts (1.7%). For pts with GIP, median time to first event was 2.1 mo; the majority of events were non-fatal and occurred within the first 3 mo after starting BV. BC including GI medical history (chronic aspirin or NSAID use, peptic ulcer disease, diverticulosis) were similar in pts with or without GIP and with earlier or later GIP onset (≤ or >3 mo from start of BV). Although adjusted models did not show any significant BC, GIP rates were numerically higher in pts with primary tumor intact (2.6%) vs. resected (1.6%). Furthermore, univariate analyses revealed a significant difference between intact (2.3%) and resected (0.8%) primary tumor for earlier GIP (≤3 mo from start of BV). The majority of pts with GIP had at least one of the following: acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, tumor at GIP site, abdominal carcinomatosis, prior abdominal or pelvic radiation therapy. Conclusions: Preliminary analyses indicate the incidence of GIP in this large, community-based observational registry is similar to that previously reported in phase III mCRC trials with BV. No associations between specific BCs and an increased risk of GIP were identified. Patients with primary tumor intact were more likely to incur a GIP within the first 3 mo of starting BV and CT. [Table: see text]

Self-reported adherence to regorafenib for metastatic colorectal cancer: A retrospective cohort study.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 783-783 ◽  
Author(s):  
Kazuyoshi Kawakami ◽  
Mitsukuni Suenaga ◽  
Azusa Soejima ◽  
Kazuo Sugita ◽  
Takashi Yokokawa ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multivariate Analysis ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Skin Reaction ◽  
Liver Dysfunction ◽  
Dose Intensity ◽  
Adherence Rate ◽  
Clinical Factor ◽  
Hand Foot Skin Reaction

783 Background: Regorafenib is an oral multikinase inhibitor for metastatic colorectal cancer (mCRC) and it is frequently involved in various adverse events. The clinical factors affecting adherence to regorafenib remain unclear. The aim of this study is to evaluate adherence to regorafenib in patients with mCRC and to identify candidate factors which might have influence on adherence to regorafenib. Methods: We evaluated 106 consecutively enrolled patients with mCRC who received regorafenib between May 18, 2013 and March 2, 2015 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. Adherence to regorafenib was checked by pharmacists using a self-reported treatment diary for patients at a pharmaceutical outpatient clinic. The adherence rate was defined as the number of actual intakes per 21 intakes scheduled in each cycle. We retrospectively surveyed median relative dose intensities of regorafenib and the factors deteriorating adherence across three cycles. Univariate analyses were then performed using patient socio-demographic factors and clinical factor. Multivariate analysis was performed using logistic regression. Significance levels for uni- and multivariate analyses were p < 0.2 and p< 0.05, respectively. Results: A total of 81 patients were evaluated in the study analysis. Adherence rates were 64.4% in the first cycle of regorafenib treatment, 77.4% in the second cycle, and 83.8% in the third cycle. The median relative dose intensity was 57.6%. The most common reasons for non-adherence were hand-foot skin reaction (34.3%, 331 instances), and liver dysfunction (15.3%, 148 instances). In multivariate analysis, increased non-adherence to regorafenib was significantly associated with gender (female) [odds ratio (OR) = 0.20; 95% confidence interval (CI): 0.06-0.68, p = 0.01] and adverse events ( ≥ Grade 3) [OR = 3.16; 95% CI: 1.00-9.97, p= 0.04) in the first cycle.] Conclusions: The high frequency of treatment-related hand-foot skin reaction and liver dysfunction is the main factor affecting adherence to regorafenib. Intensive supportive care in the management of these symptoms could assist adequate adherence to regorafenib.

Phase III Comparison of Two Irinotecan Dosing Regimens in Second-Line Therapy of Metastatic Colorectal Cancer

2003 ◽  
Vol 21 (5) ◽  
pp. 807-814 ◽  
Author(s):  
Charles S. Fuchs ◽  
Melvin R. Moore ◽  
Graydon Harker ◽  
Luis Villa ◽  
David Rinaldi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Significant Difference ◽  
Global Quality Of Life ◽  
Grade 3

Purpose: Randomized trials in fluorouracil (FU)-refractory colorectal cancer demonstrate significant survival advantages for patients receiving irinotecan. We prospectively compared the efficacy and tolerability of two irinotecan regimens (once a week for 4 weeks followed by a 2-week rest period [weekly] v once every 3 weeks) in such patients. Patients and Methods: This multicenter, open-label, phase III study randomly assigned patients in a 1:2 ratio to irinotecan given either weekly (125 mg/m2) or once every 3 weeks (350 mg/m2, or 300 mg/m2 in patients who were ≥ 70 years of age, who had Eastern Cooperative Oncology Group performance status equal to 2, or who had prior pelvic irradiation). Results: With median follow-up of 15.8 months, there was no significant difference in 1-year survival (46% v 41%, respectively; P = .42), median survival (9.9 v 9.9 months, respectively; P = .43), or median time to progression (4.0 v 3.0 months, respectively; P = .54) between the two regimens. Grade 3/4 diarrhea occurred in 36% of patients treated weekly and in 19% of those treated once every 3 weeks (P = .002). Grade 3/4 neutropenia occurred in 29% of patients treated weekly and 34% of those treated once every 3 weeks (P = .35). Treatment-related mortality occurred in five patients (5.3%) receiving irinotecan weekly and three patients (1.6%) given therapy once every 3 weeks (P = .12). Global quality of life was not statistically different between treatment groups. Conclusion: Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea.

scholarly journals Correlation between UGT1A1 gene polymorphism and irinotecan chemotherapy in metastatic colorectal cancer：a study from Guangxi Zhuang

2020 ◽  
Author(s):  
Shaojun Chen ◽  
Li Hua ◽  
Chenjun Feng ◽  
Qia Mo ◽  
Mengzhuan Wei ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Gene Polymorphism ◽  
Metastatic Colorectal Cancer ◽  
Heterozygous Mutation ◽  
Wild Type ◽  
Ugt1a1 Gene ◽  
Geographical Regions ◽  
Significant Difference ◽  
Homozygous Mutant ◽  
Grade 3

Abstract Background: UGTlA1 gene polymorphism has different distribution in different ethnicities, geographical regions and ethnic groups, which may lead to different toxicity and efficacy of irinotecan. The study aimed to explore the correlation of UGT1A1 gene polymorphism of Guangxi Zhuang metastatic colorectal cancer (mCRC) with irinotecan -based chemotherapy, in order to develop an individualized irinotecan regimen for mCRC patients of Guangxi Zhuang. Methods: From June 2013 and June 2015, a total of 406 patients of Guangxi who were histologically diagnosed as metastatic colorectal cancer with 102 patients of this cohort with three generations of Zhuang, and 86 patients that conformed to inclusion and exclusion criteria were competitively enrolled . The distribution of UGT1A1 gene polymorphism was analyzed-retrospectively in all patients. Pyrosequencing method was used to detect the UGT1A1 * 28 and * 6 gene polymorphism in the 86 Guangxi Zhuang mCRC patients. After first-line chemotherapy with FOLFIRI regimen, the relationship between gene polymorphism of UGT1A1 and adverse reactions, and efficacy of Irinotecan were analyzed with χ2 test and Kaplan-Meier method.Results: UGT1A1 * 28 wild-type (TA6 / 6), heterozygous mutant (TA6 /7) and homozygous mutant (TA7 / 7) accounted for 69.8%, 30.2% and 0%, respectively. UGT1A1 * 6 wild type (G / G), heterozygous mutation type (G / A) and homozygous mutant (A / A) accounted for 76.7%，20.9% and 2.3%，respectively.UGT1A1 * 28 TA6 / 7 type could increase the risk of grade 3-4 diarrhea (P=0.027), which did not increase the risk of grade 3-4 neutropenia (P=0.092). UGT1A1 * 6 G / A and A / A type could increase the risk of grade 3-4 diarrhea and neutropenia (P=0.001; P=0.017). After chemotherapy with FOLFIRI, there was no significant difference in response rate (RR) (P=0.729; P=0.745) or in median progression-free survival (mPFS) between the wild-type, mutant treatment of UGT1A1 * 28 and UGT1A1 * 6 (7.0 m vs 7.4 m, P=0.427; 6.9 m vs 7.0m P=0.408).Conclusions: The distribution of UGT1A1*28 and UGT1A1* 6 gene polymorphism in Guangxi Zhuang patients were differed from the existing reported of European people and Chinese Han population. The UGT1A1 gene polymorphism with irinotecan chemotherapy-associated diarrhea and neutropenia were closely related. There was no significant association between UGT1A1 gene polymorphism and therapeutic efficacy of irinotecan.

Association of Hand-Foot Skin Reaction with Regorafenib Efficacy in the Treatment of Metastatic Colorectal Cancer

Oncology ◽  
2019 ◽  
Vol 96 (4) ◽  
pp. 200-206 ◽  
Author(s):  
Kazuo Kobayashi ◽  
Kazuyoshi Kawakami ◽  
Takashi Yokokawa ◽  
Takeshi Aoyama ◽  
Kenichi Suzuki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Skin Reaction ◽  
Hand Foot Skin Reaction

Retrospective cohort study on the safety and efficacy of panitumumab for patients with metastatic colorectal cancer: The HGCSG1002 study—Analysis of after cetuximab refractory.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 541-541
Author(s):  
Yoshimitsu Kobayashi ◽  
Hiraku Fukushima ◽  
Takahide Sasaki ◽  
Satoshi Yuki ◽  
Hiroyuki Okuda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Daily Practice ◽  
Free Survival ◽  
Naive Group ◽  
Significant Difference ◽  
Heavily Pretreated ◽  
Grade 3 ◽  
Egfr Antibody

541 Background: In the previous studies, panitumumab (Pmab) has been demonstrated the efficacy for patients with metastatic colorectal cancer (mCRC) in all treatment lines. It is still controversial about the efficacy of Pmab for patients that had progressed on prior cetuximab (Cmab), though there had been a few reports (from Metges et al. and Wadlow et al.) regarding the efficacy of Pmab after Cmab refractory or intolerance. To evaluate the efficacy and safety of Pmab in patients with cetuximab-refractory mCRC, in comparison with anti-EGFR antibody naïve patients (Cmab-naïve) and Cmab-refractory or intolerance patients (prior-Cmab). Methods: Two hundred patients with mCRC treated by Pmab contained chemotherapy were retrospectively registered from 20 centers in Japan (HGCSG 1002 study). Of these, the patients that were refractory to or intolerant for 5-FU/ irinotecan/ oxaliplatin, and were administered Pmab monotherapy were included in this analysis. Results: Of 93 patients (44 prior-Cmab and 49 Cmab-naïve) were evaluated. There were no significant differences in the baseline characteristics of the patients in each group. The incidence of Grade 3 or higher any skin toxicities were higher in the Cmab-naïve (26.5.%) than in the prior-Cmab (11.4%). The overall response rate (RR) was not significantly difference (prior-Cmab/ Cmab-naïve, 9.1%/ 10.2%), but the disease control rate (DCR) was slightly higher in Cmab-naïve group (38.6%/ 55.1%, p=0.15). Progression free survival (PFS) and overall survival (OS) were follows: prior-Cmab/ Cmab-naïve, 2.8m/ 3.1m, 6.8m / 9.5m. There was a significant difference between the two groups in OS curve (p=0.04). Conclusions: Pmab was safely administered to heavily pretreated mCRC patients in daily practice. Although there were no significant differences in RR, DCS and PFS between prior-Cmab and Cmab-naïve, but the median OS was longer for the Cmab-naïve group compared with the prior-Cmab group. Therapeutic efficacies of Pmab for prior-Cmab patients did not comparable to those for Cmab-naïve patients. We are now performing a phase II trial on the efficacy of Pmab for Cmab-refractory mCRC patients.

A multinational, randomized, phase III trial of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab as second-line therapy for metastatic colorectal cancer: Safety analysis of Asian XELIRI project (AXEPT).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 681-681
Author(s):  
Masato Nakamura ◽  
Tae Won Kim ◽  
Rui-hua Xu ◽  
Young Suk Park ◽  
Yong Sang Hong ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Safety Analysis ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Line Therapy ◽  
Significant Difference ◽  
Grade 3

681 Background: Several studies have shown that capecitabine plus irinotecan (XELIRI) has promising efficacy and safety in patients with metastatic colorectal cancer. AXEPT is a non-inferiority, phase III comparison of XELIRI with or without bevacizumab vs 5-fluorouracil/folinic acid plus irinotecan (FOLFIRI) with or without bevacizumab as second-line therapy in patients with metastatic colorectal cancer. Methods: We undertook an open-label, non-inferiority, randomized phase III trial in South Korea, China and Japan. Patients were randomized 1:1 to XELIRI (irinotecan 200 mg/m2 on day 1 plus capecitabine 800 mg/m2 twice daily for 2 weeks in a 3-week cycle) with or without bevacizumab 7.5 mg/kg or FOLFIRI with or without bevacizumab. The primary endpoint was overall survival. Results: From December 2013 to August 2015, 650 patients were enrolled and 625 (311 in FOLFIRI and 314 in XELIRI) were included to safety analysis at the cutoff dates on August 31, 2016. Patient baseline characteristics including KRAS status and UGT1A1 gene polymorphism were similar between the two treatment arms. Prior chemotherapy with oxaliplatin was given to 97.4% in both arms. The overall incidence of grade 3-4 toxicity was 73% in FOLFIRI arm and 53.2% in XELIRI arm. Whereas FOLFIRI was associated with more grade 3-4 neutropenia (43.7% vs 16.2%), leucopenia (13.5% vs 7.3%) and all grades anemia (80.4% vs 69.4%) than XELIRI, XELIRI was associated with more all grades hand-foot syndrome (34.1% vs 14.8%) and grade 3-4 diarrhea (7.0% vs 3.2%). There was no significant difference in febrile neutropenia (4.2% in FOLFIRI and 2.9% in XELIRI). The addition of bevacizumab did not alter safety profiles between XELIRI and FOLFIRI. There was a treatment-related death in FOLFIRI arm (0.3%). Conclusions: Both FOLFIRI and XELIRI were safe and well tolerated, though there were differences in the rates and toxicity profiles at which adverse events occur. Clinical trial information: NCT01996306. UMIN000012263.

HGCSG 1301: A multicenter, double-blind, randomized controlled phase II trial comparing Hange-shashin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer treated with IRIS/Bev as second-line therapy—Updated analysis of antitumor efficacy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 108-108
Author(s):  
Atsushi Ishiguro ◽  
Hiroshi Nakatsumi ◽  
Tetsuhito Muranaka ◽  
Yasuyuki Kawamoto ◽  
Satoshi Yuki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Controlled Study ◽  
Second Line ◽  
Second Line Therapy ◽  
Double Blind ◽  
Line Therapy ◽  
Significant Difference ◽  
Grade 3

108 Background: IRIS (irinotecan plus S-1) plus bevacizumab (IRIS/Bev) is one of the standard chemotherapies in Japan for metastatic colorectal cancer (mCRC) as the first-line or second-line therapy. The most frequent non-hematological adverse event of IRIS was diarrhea. Hange-shashin-to (HST) is a Kampo medicine which is used in Japan for the treatment of gastritis, stomatitis, and diarrhea. We conducted this study to evaluate the usefulness of HST to prevent diarrhea in patients with mCRC receiving IRIS/Bev as the second-line therapy. Methods: This trial was designed as a multicenter, randomized, double-blind, placebo-controlled study. We administrated HST 2.5g or placebo PO t.i.d. x 3 months from the first treatment course of IRIS/Bev. The primary endpoint is proportion of ≥grade 3 diarrhea assessed by CTCAE v4.0. This study is registered with UMIN-CTR, number UMIN000012276. Results: Between Jan 1, 2014 and Mar 31, 2017, 59 patients from 11 institutes in Japan were randomly assigned to receive HST (n = 28, Group H) or placebo (n = 29, Group P). The proportions of ≥grade 3 diarrhea was 10.7% in Group H and 13.8% in Group P (p = 1.00). The other major adverse events of ≥grade 3 in Group H vs Group P were fatigue (3.6% vs 10.3%), anorexia (14.3% vs 10.3%), and nausea (0.0% vs 3.4%). The overall response rate was 13.6% in Group H vs 7.7% in Group P (p = 0.65). There were not statistically significant differences in median progression-free survival (mPFS), median time to treatment failure (mTTF), and median overall survival (mOS) between Group H and Group P ( mPFS 7.9 vs 5.9 months; p = 0.35; mTTF 3.8 vs 5.6; p = 0.466; mOS 17.0 vs 15.3 months; p = 0.750). Conclusions: Prophylactic HST could not reduce the severity of diarrhea during IRIS/Bev. The update analysis of anti-tumor efficacy showed that IRIS/Bev had promising survival benefit but there is not statistically significant difference between HST and placebo. Clinical trial information: UMIN000012276.

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