Startseite Kongressberichte 2019 ESMO 2019 Gastrointestinal Cancers Metastatic Colorectal Cancer (mCRC)

The cost of adverse event management in patients with RAS wild-type mCRC treated with first-line cetuximab and panitumumab & Choice of trifluridine/tipiracil (TAS-102) Posters

596P:

Karl Patterson et al: The cost of adverse event management in patients with RAS wild-type metastatic colorectal cancer treated with first-line cetuximab and panitumumab: an Italian healthcare payer perspective

Conclusions: Fewer AEs for cet+CT may result in markedly lower AE management costs vs pan+CT. Although results should be considered together with overall costs and clinical outcomes, cet+CT could decrease the cost burden on the Italian National Health Service and AE burden for patients with mCRC.

600P:

Stavraka et al. Trifluridine/tipiracil in metastatic colorectal cancer: an updated multicenter real-world analysis on efficacy, safety and predictive factors.

Conclusions

These results are consistent with the efficacy and toxicity outcomes from RECOURSE study. However, lower disease control rates and higher rates of dose reductions are seen in the real-world population. Pre-treatment NLR and CEA could serve as potential markers for patient selection. Prospective validation is needed.

See also: 

Chara Stavraka et al. Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer: A multicenter United Kingdom study. Abstract 668

617P:

Qvortrup et al. Early response evaluation and CEA response in patients treated in a Danish randomized study comparing trifluridine/tipiracil (TAS-102) with or without bevazicumab in patients with chemorefractory metastatic colorectal cancer (mCRC).

Conclusions

FTD/TPI in combination with bevacizumab prolong PFS and OS and is a new option in patients with chemo-refractory mCRC. Predictive markers for early progression are ongoing and will be presented.

See also: 

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

Krzysztof Lesniewski-Kmak et al. Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): results of the primary analysis

619P:

K.Kazama et al. JFMC51-1702-C7: Phase II study investigating efficacy and safety of trifluridine/tipiracil (FTD/TPI)       plus bevacizumab (BEV) in patients (pts) with metastatic colorectal cancer (mCRC)    refractory or intolerant to standard chemotherapies.

Conclusions

FTD/TPI plus BEV showed a promising activity with an acceptable safety profile for previously treated mCRC harboring either RAS wild-type or mutant. Survival outcome will be presented at the meeting.

See also:

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

Daisuke Kotani et al.  Safety and efficacy of trifluridine/tipiracil (TAS-102) plus bevacizumab in clinical practice for patients with refractory metastatic colorectal cancer.

620P:

Makiyama et al. Bevacizumab plus trifluridine/tipiracil in elderly patients with previously untreated metastatic colorectal cancer (KSCC 1602): A single-arm, Phase 2 study.

Conclusions

In this Phase 2 KSCC 1602 trial of bevacizumab plus FTD/TPI, the primary endpoint of PFS was achieved. This combination therapy showed favorable survival outcomes with an acceptable safety profile for elderly patients with previously untreated metastatic colorectal cancer.

See also:

Eiji Oki et al. Trifluridine/tipiracil plus bevacizumab in elderly patients with previously untreated metastatic colorectal cancer (KSCC1602): A multicenter, phase II clinical trial. Abstract 3548

Kuboki Y et al. TAS-102 plus bevacizumab for patients with metastatic colorectal cancer refractory to standard therapies (C-TASK FORCE): an investigator-initiated, open-label, single-arm, multicentre, phase 1/2 study.

665TIP:

Andre et al. SOLSTICE, a phase 3, randomized, open label study of trifluridine/tipiracil + bevacizumab (bev) versus capecitabine + bev for the 1L treatment of patients with unresectable metastatic colorectal cancer (mCRC) who are not candidates for intensive therapy.

This phase 3, international, open-label, randomized study will include 854 first-line mCRC-patients, not candidate for intensive oxaliplatin- or irinotecan-based chemotherapy and non-eligible for curative resection, according to investigator’s judgment and in relation with age, performance status (PS), low tumour burden, comorbidities or non-clinical reasons. The stratification factors are ECOG PS (0 vs 1 vs 2), tumour localization (right vs left) and reason for non-eligibility to intensive therapy. Patients will be randomly allocated to trifluridine/tipiracil (35 mg/m2 given orally bid on days 1–5 and 8–12 in a 28-day cycle) plus bev (5 mg/kg on days 1 and 15 of a 28-day treatment cycle) or capecitabine (1250 or 1000 mg/m²/dose bid on days 1-14 in a 21-day) plus bev (7.5 mg/kg on day 1 in a 21-day treatment cycle). The primary endpoint is PFS and the key secondary endpoint is OS. Other secondary endpoints include safety and quality of life assessed by EORTC QLQ-C30 and EQ-5D questionnaires. Patients will also undergo comprehensive geriatric assessment using G8 questionnaire and Charlson Comorbidity Index at baseline. Inclusion of the first patient was done in March 2019. It is planned to open approximately 200 centers in 25 countries.

Clinical trial identification: NCT03869892; March 11, 2019.

DOWNLOAD ALL FIVE POSTERS: 

5POSTERS