Exploratory analysis of the effect of FTD/TPI in patients treated in RECOURSE by prognostic factors.

Abstract

677 Background: The Phase III RECOURSE trial, in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies, demonstrated that trifluridine/tipiracil (FTD/TPI) significantly extended overall survival (OS) and progression-free survival (PFS) versus placebo in all subgroups, regardless of age, geographical origin, or KRAS status, with acceptable safety. Literature reports have shown optimal benefit for pts with low tumor burden (< 3 metastatic sites), indolent disease (≥ 18 mo since diagnosis of first metastasis), ECOG PS 0-1, and no liver metastasis when treated in late line mCRC. Methods: This exploratory post hoc analysis of RECOURSE (all ECOG 0-1) compared pts on FTD/TPI or placebo with good prognostic characteristics (GPC; low tumor burden and indolent disease) and poor prognostic characteristics (PPC; high tumor burden and/or aggressive disease). These subgroups were then analyzed by liver metastasis at baseline, ECOG PS, KRAS status and age. Results: Baseline characteristics were generally similar between the two groups. GPC placebo pts performed better than the PPC placebo pts, but worse than the GPC pts treated with FTD/TPI. GPC pts treated with FTD/TPI showed median OS of 9.3 mo versus 5.3 mo in PPC pts (HR 0.46; 95% CI: 0.37, 0.57; p < 0.0001); there was a similar effect for PFS. GPC pts had significantly better mOS and mPFS regardless of age (≥ 65 vs. < 65 y), ECOG PS (0–1), KRAS status (mutant vs. wildtype), and liver metastasis (y/n). No liver metastasis was the best prognostic factor: mOS in such pts treated with FTD/TPI was 16.4 mo and 7.6 mo in the GPC (n = 97) and PPC (n = 35) groups, respectively (HR 0.42; 95% CI: 0.24, 0.74; p < 0.0019); there was a similar effect for PFS. Pts with ECOG PS 0 at baseline remained PS 0-1 at discontinuation in 96% of the GPC group. 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.

Current Options for Third-line and Beyond Treatment of Metastatic Colorectal Cancer. Spanish TTD Group Expert Opinion

“…23 The Italian real world data (RWD) study showed a PS 0, a normal lactate dehydrogenase, and time from diagnosis > 18 months, which were independently associated with a greater likelihood of being progression-free at 6 months 20 ( Table 2). A recent analysis of the RECOURSE 28 compared patients with good prognostic characteristics (GPCs), defined as low tumor burden (< 3 metastatic sites), indolent disease (! 18 months since diagnosis of first metastasis), Eastern Cooperative Oncology Group PS 0 to 1, and no liver metastasis and patients with poor prognostic characteristics (PPCs), defined as high tumor burden and/or aggressive disease.…”

Trifluridine / tipiracil (FTd / TPI, TAS-102) in the treatment of patients with metastatic colon cancer: from preclinical experiments to routine clinical practice

“…Выделенные на основании данного анализа прогностические группы хорошего (индолентное течение болезни и небольшая распространенность) и неблагоприятного прогноза показали значимые различия в выживаемости без прогрессирования и общей выживаемости независимо от возраста пациента, статуса по шкале ECOG, мутационных характеристик опухоли и наличия метастазов в печени. Отсутствие метастазов в печени явилось наиболее значимым благоприятным фактором в процессе терапии FTD / TPI: медианы общей выживаемости составили 16,4 мес против 7,6 мес соответственно [103]. В исследовании A. Tanaka и соавт.…”

Effect Analysis of Positive Molecular Therapy in Surgical Nursing Based on Data Transformation Analysis

“…DBT and ACT can help them to improve their tolerance of negative feelings, reduce behavioral impulses, and enhance their ability to cope effectively with illness [5]. As an important method of psychological treatment for psychological disorders, positive thinking therapy has also played a key role in promoting patients' physical and mental health in clinical practice [6]. Domestic and international studies have shown that the interventions of positive thinking therapy in hypertension, diabetes, chronic pain, cancer, chronic inflammation, and perioperative patients can effectively relieve patients' physical pain, improve patients' emotional disorders, reduce psychological stress, and improve the quality of daily life, which have shown good results in clinical application [7].…”