Startseite Kongressberichte & Archiv The Gastrointestinal Cancers Symposium 2019 Presentations with trifluridine/tipiracil (FTD/TPI) at the Gastrointestinal Cancers Symposium

Presentations with trifluridine/tipiracil (FTD/TPI)/TAS-102 at the Gastrointestinal Cancers Symposium

Thursday, January 17, 2019

Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastric cancer (mGC) with or without prior gastrectomy: Results from a phase III study (TAGS).

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

VideoSlides

Saturday, January 19, 2019

Health-related quality of life in the early-access phase IIIb study of trifluridine/tipiracil in pretreated metastatic colorectal cancer (mCRC): Results from PRECONNECT study.

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

Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) in patients with metastatic colorectal cancer (mCRC): A single institution retrospective study.

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

Validation of cost-effectiveness of trifluridine/tipiracil versus best supportive care and regorafenib for previously treated metastatic colorectal cancer in the UK using phase IIIb PRECONNECT early access clinical trial data in the real world setting.

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

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

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

QoL from TASCO1: Health-related quality of life of trifluridine/tipiracil-bevacizumab and capecitabine-bevacizumab as first-line treatments in metastatic colorectal cancer patients not eligible for intensive chemotherapy—Results from the TASCO1 phase II study.

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

Impact of tumor growth rate during preceding treatment on tumor response to nivolumab or irinotecan in advanced gastric cancer.

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

Phase I/II study of panitumumab (PANI) combined with trifluridine/tipiracil (FTD/TPI) in patients (pts) with previously treated RAS wild-type (wt) metastatic colorectal cancer (mCRC): Final results of APOLLON study.

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

Multicenter phase Ib/ II study of biweekly trifluridine/tipiracil with bevacizumab combination for patients with metastatic colorectal cancer refractory to standard therapies (BiTS study).

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

Randomized study evaluating trifluridine/tipiracil (TAS-102) versus + trifluridine/tipiracil + bevacizumab as last-line therapy in patients with chemorefractory unresectable metastatic colorectal cancer (mCRC).

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

Evaluation of health-related quality of life (HRQoL) in patients with metastatic colorectal cancer (mCRC): A prospective, multicenter, open-label, double-arm trial of trifluridine/tipiracil (FTD/TPI) versus best supportive care (BSC).

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

A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).

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

The combination of TAS-102 and bevacizumab as the third-line chemotherapy for metastatic colorectal cancer (TAS-CC3 Study).

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

A systematic review and network meta-analysis of regorafenib and TAS-102 in refractory metastatic colorectal cancer.

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

FOLFOX rechallenge versus regorafenib in patients with metastatic colorectal cancer refractory to standard chemotherapy: A retrospective analysis.

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

CCTG CO.26 trial: A phase II randomized study of durvalumab (D) plus tremelimumab (T) and best supportive care (BSC) versus BSC alone in patients (pts) with advanced refractory colorectal carcinoma (rCRC).

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