Presentations with trifluridine/tipiracil (FTD/TPI)/TAS-102 at the Gastrointestinal Cancers Symposium
Thursday, January 17, 2019
Session: Oral Abstract Session A: Cancers of the Esophagus and Stomach
Author(s): David H. Ilson, et al. Abstract #: 3
CONCLUSION:• FTD/TPI prolonged survival versus placebo regardless of gastrectomy • HematologicAEs such as neutropenia/leukopenia may have been somewhat more frequent among FTD/TPl-treated patients with gastrectomy than in the overall population - This did not result in more treatment discontinuations • Exposure to FTD/TPI was similar between patients with gastrectomy and those in the overall population • FTD/TPI is an effective treatment option with a manageable safety profile for patients with mGC regardless of prior gastrectomy.
Clinical trial information: NCT02500043
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Julien Taieb, et al. Abstract #: 638
Conclusions: The first prospective data on QoL suggest that mCRC pts can maintain their QoL while on FTD/TPI treatment. Clinical trial information: NCT03306394
Saturday, January 19, 2019
Exploratory analysis of the effect of FTD/TPI in patients treated in RECOURSE by prognostic factors.
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Josep Tabernero, et al. Abstract #: 677
Conclusions:Low tumor burden and indolent disease indicate good prognosis in late line mCRC. Pts with no liver metastasis have the best prognosis and are likely to have longer OS. GPCs might explain the percentage of long-term responders on FTD/TPI in RECOURSE. Maintenance of ECOG PS 0–1 during treatment is crucial in the continuum of care, allowing pts to benefit from further treatment options. Clinical trial information: NCT01607957
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Anuj K. Patel, et al. Abstract #: 592
Conclusions: In this single institution study, TTD and OS were similar between pts treated with FTD/TPI and REG. Fewer pts treated with FTD/TPI than REG discontinued due to toxicities or required dose modification. Reported responses rates were higher in FTD/TPI pts. Older pts (≥ 65 years) on FTD/TPI remained on treatment longer and had better OS than REG pts.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Javier Sabater, et al. Abstract #: 639
Conclusions:New HRQoL data from the PRECONNECT study collected in a real-world setting validated previous HRQoL inputs used to model cost-effectiveness of FTD/TPI in previously treated metastatic colorectal cancer. Clinical trial information: NCT03306394
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Chara Stavraka, et al. Abstract #: 668
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.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Vladimir Moiseyenko, et al. Abstract #: 676
Conclusions: The Global Health Scale was maintained in Trifluridine/tipiracil+bevacizumab arm as well as in the capecitabine+bevacizumab arm. No clinically relevant difference from baseline was observed over time in both groups except for few sub-scales. Clinical trial information: NCT02743221
Thursday, January 17, 2019
Session: Poster Session A: Cancers of the Esophagus and Stomach
Author(s): Kyoko Kato, et al. Abstract #: 84
Conclusions: RR was higher with NIVO than with IRI among slow growing tumors, whereas it was comparable between both drugs among rapid growing tumors. TGR during preceding treatment might be helpful for drug selection in pts with AGC who are considered for treatment with NIVO or IRI.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Yoshito Komatsu, et al. Abstract #: 624
Conclusions: PANI combined with FTD/TPI showed favorable antitumor activity with an acceptable safety profile for previously treated RAS wt mCRC, although the primary endpoint of PFS rate at 6 M did not meet the prespecified threshold. Clinical trial information: NCT02613221
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Masahito Kotaka, et al. Abstract #: 647
Conclusions: Bi-weekly FTD/TPI plus Bmab showed promising anti-tumor effect with acceptable toxicities. Clinical trial information: UMIN000029198.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Per Pfeiffer, et al. Abstract #: 637
Conclusions: In patients with chemorefractory mCRC, FTD/TPI + bevacizumab, as compared with FTD/TPI monotherapy, was associated with a significant and clinically relevant improvement in PFS and OS with tolerable toxicity. Clinical trial information: 2016-005241-23.
Saturday, January 19, 2019
Session: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Meinolf Karthaus, et al. abstr TPS726
TALLISUR started 09/2017 (EudraCT-No 2017-000292-83) and has recruited 160 mCRC pts in total (17th Sep 2018). Clinical trial information: 2017-000292-83.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Michael Cecchini, et al. Abstract #: 630
Conclusions:The RP2D of TAS-102 is 35 mg/m2 in combination with oxaliplatin 85 mg/m2. No DLTs were observed and no unexpected AEs were seen. The DCR in this heavily pretreated patient population is encouraging. Phase II is now enrolling at this dose (NCT 02848079). Clinical trial information: NCT02848079
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Chihiro Kosugi, et al. Abstract #: 614
Conclusions: This is the first study which involves the combination of TAS-102 and bevacizumab as the 3rd line chemotherapy in the setting beyond cytotoxic doublet for the patients with mCRC. This study met its primary endpoint PFS, which is comparable to the results of C-TASK FORCE study. This combination has a potential to be one of the therapeutic options of the 3rd line chemotherapy for mCRC. Clinical trial information: 000022438.
Saturday, January 19, 2019
Session: Poster Walks: Cancers of the Colon, Rectum, and Anus
Author(s): Mohamad Bassam Sonbol, et al.Abstract #: 619
Conclusions: Regorafenib 160 and TAS-102 appear to have similar efficacy. Rego 80+ is shown to be superior to BSC. A trend for improved OS was observed with Rego 80+ versus Rego 160 or TAS 102.
Saturday, January 19, 2019
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Maria Alessandra Calegari, et al. Abstract #: 669
Conclusions: Our study, although retrospective and small-sized, compared for the first time to our knowledge the efficacy of CT rechallenge to regorafenib in refractory mCRC. In our analysis, CT rechallenge with FOLFOX proved to be superior compared to regorafenib, with a survival and response benefit in pretreated mCRC. The survival benefit observed for rechallenge might be explained by the significantly higher tumor shrinkage achieved with CT rechallenge compared to regorafenib. Our results warrant further confirmation in wider and/or prospective analyses.
Saturday, January 19, 2019
Session: Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus
Author(s): Eric Xueyu Chen, et al. Abstract #: 481
Conclusions:D+T significantly prolonged OS in pts with rCRC and preserved quality of life. Adverse events were more frequent with D+T. This is the first study showing that combined PD-L1 and CTLA-4 inhibition prolongs survival in pts with advanced refractory CRC not selected for dMMR. Clinical trial information: NCT02870920