scholarly journals 190P Observational cohort study of 1st line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Sub-group analysis by the Glasgow Prognostic Score (GPS)

2016 ◽  
Vol 27 (suppl_9) ◽  
Author(s):  
T. Sasaki ◽  
S. Yuki ◽  
Y. Kawamoto ◽  
K. Harada ◽  
T. Meguro ◽  
...  
2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 522-522
Author(s):  
Michio Nakamura ◽  
Satoshi Yuki ◽  
Kentaro Sawada ◽  
Ayane Oba ◽  
Atsushi Sato ◽  
...  

522 Background: A few reports have shown the efficacy of bevacizumab (BV) independent of the KRAS Exon2 mutational status (KRAS). We performed a sub-group analysis by KRAS from the HGCSG0802 observational cohort study that investigated 115 patients (pts) treated with 1st line BV for metastatic colorectal cancer (mCRC). Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), response rate (RR), and safety. The key eligibility criteria were with evaluable lesions, older than 20 years, ECOG PS 0-2. In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. Univariate and multivariate analysis for PFS and OS were performed using patient characteristics. Survival analyses were performed with Kaplan-Meier method and Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 99 pts were evaluable for KRAS. Sixty-two pts (62.6%) had KRAS wild-type (wt) and 37 pts (37.4%) had mutation (mt). The pts characteristics between those with wt and with mt were generally balanced except for PS 0 (91.9% in wt, 75.7% in mt; p = 0.036) and lung metastasis (33.9% in wt, 62.2% in mt; p = 0.007). RR was 70.0% in wt versus 65.7% in mt. Adverse events related to BV were almost balanced except for bleeding (any grade) (30.6% in wt, 13.5% in mt; p = 0.088). The median PFS and OS was 9.9 and 26.8 months in wt versus 7.9 and 17.5 months in mt (PFS ; HR 1.519, p = 0.064 and OS ; HR 1.944, p = 0.005). In Cox multivariate analysis, KRAS mt showed significantly shorter PFS and OS (PFS ; HR 1.637, p = 0.045 and OS ; HR 2.132, p = 0.005). Conclusions: In this cohort, depending on the KRAS Exon2 mutational status, severe adverse events were no significant difference. The multivariate analysis showed that PFS and OS were significantly longer in the KRAS Exon2 wild-type patients. So, KRAS Exon2 mutational status can be a predictive and prognostic marker in bevacizumab combined 1st line chemotherapy. Clinical trial information: UMIN000018935.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 527-527 ◽  
Author(s):  
Kazuteru Hatanaka ◽  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Hiraku Fukushima ◽  
Hirohito Naruse ◽  
...  

527 Background: A few reports have shown no difference between the efficacy of infusional FU and that of oral FU (Capecitabine/S-1) for colorectal cancer, and some studies have reported the non-inferiority between infusional FU/Oxaliplatin (OX) and oral FU/OX for metastatic colorectal cancer (mCRC). We performed a sub-group comparison between infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) from the HGCSG0802 observational cohort study with investigated Japanese patients (pts) treated with first line BV for mCRC. Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety and so on. The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens.In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. PFS and TTF were compared using log-rank test. Results: Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p=0.012) and synchronous liver metastases (mets) (93.8% in iFU/78.8% in oFU; p=0.040). Adverse events ≥grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p=0.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p=0.001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p=0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p=0.835). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between infusional FU/OX and oral FU/OX, and the profiles of adverse events varied from each regimens.


2018 ◽  
Vol 24 (3) ◽  
pp. 358-365 ◽  
Author(s):  
Matteo Franchi ◽  
Sandro Barni ◽  
Giovanna Tagliabue ◽  
Paolo Ricci ◽  
Walter Mazzucco ◽  
...  

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 782-782
Author(s):  
Takenori Takahata ◽  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Kazuaki Harada ◽  
Hiraku Fukushima ◽  
...  

782 Background: A few reports have shown the efficacy of bevacizumab (BV) independent of the KRAS Exon2 mutational status (KRAS). We performed a sub-group analysis by KRAS from the HGCSG0802 observational cohort study with investigated 115 patients (pts) treated with first line BV for metastatic colorectal cancer (mCRC). Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety, etc. The key eligibility criteria were with evaluable lesions, older than 20 years, ECOG PS 0-2. In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. Univariate and multivariate analysis for PFS were performed using patient characteristics. Survival analyses were performed with Kaplan-Meier method, log-rank test, and Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 98 pts were evaluable for KRAS. Sixty-one pts (62.2%) had KRAS wild-type (wt) and 37 pts (37.8%) had mutation (mt). The pts characteristics between those with wt and with mt were generally balanced except for PS 0 (91.8% in wt, 75.7% in mt; p=0.037) and lung metastasis (34.4% in wt, 62.2% in mt; p=0.012).The median TTF was 7.4 months in wt versus 6.6 months in mt, and RR was 69.5% in wt versus 65.7% in mt. Adverse events related to BV were almost balanced except for bleeding (any grade) (31.1% in wt, 13.5% in mt; p=0.056).The median PFS was 9.9 months in wt versus 7.9 months in mt (HR=1.506; p=0.071). Although KRAS mt showed shorter PFS, there were not significant difference regardless of KRAS in Cox multivariate analysis (HR 1.314, 95% CI, 0.820-2.107, p=0.257). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. Depending on the KRAS Exon2 mutational status, efficacy, and adverse events were no significant difference. We plan to conduct further follow up for survival, and to perform this analysis again.


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