Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 – REGOLD

Aparicio, Thomas; Darut-Jouve, Ariane; Akouz, F. Khemissa; Montérymard, Carole; Artru, Pascal; Cany, Laurent; Romano, O.; Valenza, B.; Foll, Christine Le; Delbaldo, Catherine; Falandry, Claire; Monnereau, Emmanuelle Norguet; Abdelghani, Méher Ben; Smith, Denis; Rinaldi, Yves; Verge, Denis Père; Baize, Nathalie; Maillard, Emmanuel; Dohan, Anthony; Guetz, G. Des; Pamoukdjian, Frédéric; Lepage, Côme

doi:10.1016/j.jgo.2020.04.001

Cited by 12 publications

(7 citation statements)

References 29 publications

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“…These guidelines recommend for all patients ≥ 65 years with cancer to have an evaluation of functional status, physical performance and falls, comorbid conditions, depression, social activity/support, nutritional status, and cognition, but do not favour one screening test over another [46]. Screening tools are available and demonstrated their feasibility in several recently published clinical trials including phase I but none in mGC [132][133][134]. The G8 screening tool +/-GA has yet to be implemented for all patients with GC above 65 years, both in the routine clinical practice and in clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Advanced oesophago-gastric adenocarcinoma in older patients in the era of immunotherapy. A review of the literature

Fouchardiere

Decoster

Samalin

et al. 2021

Cancer Treatment Reviews

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Gastric (G) and gastro-esophageal junction (GEJ) adenocarcinomas are of the most common and deadly cancers worldwide and affect mainly patients over 70 years at diagnosis. Older age has been associated in gastric cancers with distal tumour location, well-differentiated adenocarcinoma and microsatellite instability and is not identified itself as an independent prognostic factor. As immune checkpoint inhibitors recently changed the landmark of advanced G and GEJ adenocarcinomas treatment, we decided to perform a literature review to define the evidence-level of clinical data in older patients. This work underlined the lasting low -inclusion rate of older patients and -implementation rate of frailty screening tools in clinical trials in G/GEJ carcinomas. In the first-line metastatic setting, two prospective randomized phase III studies have specifically assessed the efficacy of chemotherapy in older patients with HER2-negative gastric cancers, demonstrating the feasibility of reduced dose oxaliplatin-based chemotherapy regimen in this population. Only few data are available in HER2-positive tumors, or in the second-line setting. Furthermore, no specific trial with immune checkpoint inhibitors was performed in older frail patients whereas their benefit/adverse events ratio make them attractive candidates in this patient's population. We conclude that older fit patients can be treated in the same way as younger ones and included in clinical trials. Improving the outcome of older frail patients should be the oncology community next focus by implementing targeted interventions before initiating cancer therapy and designing specific clinical trials. Frailty screening tools and geriatric data collection have to be implemented in routine-practice and clinical trials.

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Section: Discussionmentioning

confidence: 99%

Advanced oesophago-gastric adenocarcinoma in older patients in the era of immunotherapy. A review of the literature

Fouchardiere

Decoster

Samalin

et al. 2021

Cancer Treatment Reviews

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“…Del Prete et al [ 26 ] analyzed the role of regorafenib treatment line and showed that it was statistically significant for OS. Another study by Aparicio et al [ 27 ] showed that age over 80 years was associated with worse survival. However, our study did not confirm these results in the Turkish population.…”

Section: Discussionmentioning

confidence: 99%

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

Goktas Aydin,

Kavak,

Topcu

et al. 2023

Biomol Biomed

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Regorafenib, an oral multikinase inhibitor, has improved survival in metastatic colorectal cancer (mCRC) patients who have progressed on standard therapies. Our study aimed to evaluate prognostic factors influencing regorafenib treatment and assess the optimal dosing regimen in a real-life setting. We retrospectively analysed 263 patients with mCRC from multiple medical oncology clinics in Turkey. Treatment responses and prognostic factors for survival were evaluated using univariate and multivariate analysis. Of the patients, 120 were male, and 143 were female; 28.9% of tumors were located in the rectum. RAS mutations were present in 3.0% of tumors, while BRAF, K-RAS, and N-RAS mutations were found in 3.0%, 29.7%, and 25.9% of tumor tissues, respectively. Dose escalation was preferred in 105 (39.9%) patients. The median treatment duration was 3.0 months, with an objective response rate (ORR) of 4.9%. Grade ≥ 3 treatment-related toxicity occurred in 133 patients, leading to discontinuation, interruption, and modification rates of 50.6%, 43.7%, and 79.0%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.0 and 8.1 months, respectively. RAS/RAF mutation (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.1-2.3; P = 0.01), pretreatment carcinoembryonic antigen (CEA) levels (HR 1.6, 95% CI 1.1-2.3; P = 0.008), and toxicity-related treatment interruption or dose adjustment (HR 1.6, 95% CI 1.1-2.4; P = 0.01) were identified as independent prognostic factors for PFS. Dose escalation had no significant effect on PFS but was associated with improved OS (P < 0.001). Independent prognostic factors for OS were the initial TNM stage (HR 1.3, 95% CI 1.0-1.9; P = 0.04) and dose interruption/adjustment (HR 0.4, 95% CI 0.2-0.9; P = 0.03). Our findings demonstrate the efficacy and safety of regorafenib. Treatment line influences the response, with dose escalation being more favorable than adjustment or interruption, thus impacting survival.

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“…Grade 3-4 treatment-related adverse events were observed in 83% of the patients, and asthenia was the most frequent one. A trend to discontinue the study due to toxicity was observed among those older than 80, ECOG ≥ 1, and with impaired baseline autonomy [71].…”

Section: Regorafenibmentioning

confidence: 96%

Chemotherapy and Targeted Agents in the Treatment of Elderly Patients with Metastatic Colorectal Cancer

Tuca

Gallego

Ghanem

et al. 2020

JCM

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Colorectal cancer (CRC) is one of the main causes of cancer death in the elderly. The older patients constitute a heterogeneous group in terms of functional status, comorbidities, and aging-related conditions. Therefore, therapeutic decisions need to be individualized. Additionally, a higher toxicity risk comes from the fact that pharmacokinetics and pharmacodynamics of the drugs as well as the tissue tolerance can be altered with aging. Although the chemotherapy efficacy in metastatic colorectal cancer (mCRC) is similar for older and young patients, more toxicity is presented in the elderly. While the mono-chemotherapy provides the same benefit for young and older patients, doublets front-line chemotherapy improves progression-free survival (PFS) but not overall survival (OS) in the elderly. Furthermore, the benefit of the addition of bevacizumab to chemotherapy in older patients has been shown in several clinical trials, while the clinical data for the benefit of anti-epidermal growth factor antibodies are scarcer. Immunocheckpoint inhibitors could be an appropriate option for patients with microsatellite instability (MSI) tumors. A prior geriatric assessment is required before deciding the type of treatment in order to offer the best therapeutic option.

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Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 – REGOLD

Cited by 12 publications

References 29 publications

Advanced oesophago-gastric adenocarcinoma in older patients in the era of immunotherapy. A review of the literature

Advanced oesophago-gastric adenocarcinoma in older patients in the era of immunotherapy. A review of the literature

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

Chemotherapy and Targeted Agents in the Treatment of Elderly Patients with Metastatic Colorectal Cancer

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