The PANDA study: a randomized phase II study of first-line FOLFOX plus panitumumab versus 5FU plus panitumumab in RAS and BRAF wild-type elderly metastatic colorectal cancer patients

Battaglin, Francesca; Schirripa, Marta; Buggin, Federica; Pietrantonio, Filippo; Morano, Federica; Boscolo, Giorgia; Tonini, Giuseppe; Lutrino, E.S.; Lucchetti, Jessica; Salvatore, Lisa; Passardi, Alessandro; Cremolini, Chiara; Arnoldi, Ermenegildo; Scartozzi, Mario; Pella, Nicoletta; Boni, Luca; Bergamo, Francesca; Zagonel, Vittorina; Loupakis, Fotios

doi:10.1186/s12885-018-4001-x

Cited by 19 publications

(7 citation statements)

References 24 publications

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“…PANDA. This is a randomized phase II study of first-line FOLFOX plus panitumumab vs. 5FU/leucovorin plus panitumumab in older patients (≥ 70 years) with wild-type RAS and wild-type BRAF mCRC [45]. Older patients will benefit from geriatric assessment with the G8 scale and baseline CRASH scores.…”

Section: /33mentioning

confidence: 99%

Place of anti-EGFR therapy in older patients with metastatic colorectal cancer in 2020

Gilabert

Ries

Chanez

et al. 2020

Journal of Geriatric Oncology

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Section: /33mentioning

confidence: 99%

Place of anti-EGFR therapy in older patients with metastatic colorectal cancer in 2020

Gilabert

Ries

Chanez

et al. 2020

Journal of Geriatric Oncology

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“…Clinical trials can also speci cally focus on older adults with cancer and indeed there have been a number of 'elderly-speci c' trials in the last few years, highlighting that it is possible to conduct phase III trials in this patient population [24][25][26]. In the context of gastroesophageal cancer, the GO2 trial was a large phase III study which included 514 older patients with advanced gastroesophageal cancer who were un t for full dose chemotherapy and aimed to nd the optimal dosing strategy.…”

Section: Discussionmentioning

confidence: 99%

Metastatic Gastroesophageal Cancer in Older Patients – Is this Patient Cohort Represented in Clinical Trials?

Hennessy

Hamid

Keegan

et al. 2021

Preprint

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Background: Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer. Methods: A search strategy was developed encompassing Embase, PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies from1st January 1995 to 18th November 2020 were identified. These werescreened for eligibility using reference management software (Covidence; Veritas Health Innovation Ltd). Data including age inclusion/exclusion criteria and median age of participants were recorded. The percentage of patients≥65 enrolled was collected where available.The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model.Results: 363 phase III studies were identified and screened, with 66 trials remaining for final analysis. The majority of trials were Asian (48%; n = 32) and predominantly evaluated gastric malignancies, (86%; n = 56).The median age of participants was 62 (range 18-94). Thirty-two percent (n = 21) of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 (range 65-80). All studies prior to 2003 used an upper age exclusion (n = 12); whereas only 9 that started in 2003 or later did (17%). Among later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). Fifty-two percent (n = 34) of studies specified the proportion of their study population who were ≥65 years. Older patients represented only 36% of the trial populations in these studies (range 7-60%).Conclusions: Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.

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“…58 Next, as in the development and validation of the CARG studies, hematologic malignant neoplasms were excluded in our study, and the model is currently applicable only in solid tumors. This model also does not predict toxic effects from biologics [59][60][61] or immunotherapy [62][63][64] even though these agents have dramatically altered the landscape of cancer treatment. Another limitation of the CARG model is that it is used primarily to evaluate an older patient's strengths and vulnerabilities before the start of a new chemotherapy regimen, which provides a snapshot that is likely to change along the disease trajectory.…”

Section: Jama Network Open | Oncologymentioning

confidence: 99%

Use of the Cancer and Aging Research Group Predictive Model for Chemotherapy-Related Toxic Effects in a Multiethnic, Older Adult Asian Population

Pang

Low

et al. 2022

JAMA Netw Open

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ImportanceThe Cancer and Aging Research Group (CARG) prediction model for chemotherapy-related toxic effects has been developed but not yet validated in older Asian adults. In view of differences in drug metabolism and toxic effect reporting in the Asian population, the ability of this tool to guide the cancer treatment decision-making process in older Asian adults needs to be assessed.ObjectiveTo examine the validity of the CARG predictive model in a multiethnic Asian cohort of older adults.Design, Setting, and ParticipantsIn this prognostic study, patients of various Asian ethnicities 70 years or older with a solid tumor diagnosis receiving chemotherapy at the National University Cancer Institute, Singapore, were accrued from June 1, 2017, to January 1, 2019. Their risks of chemotherapy-related toxic effects were calculated using the CARG tool. A geriatric assessment was performed, and the treating oncologist (blinded to the CARG scores) was asked to give an estimated likelihood of toxic effects (low, medium, or high). Chemotherapy-related toxic effects were recorded during each clinic visit. Validation of the prediction model was performed by calculating the area under the receiver operating characteristic curve. Multivariate analyses were performed to identify variables in other domains in the geriatric assessment predicting for severe toxic effects.Main Outcomes and MeasuresGrade 3 to 5 toxic effects and hospitalization.ResultsThe study included 200 patients (median age, 74 years [range, 70-89 years]; 110 [55.0%] male; 177 [88.5%] Chinese, 17 [8.5%] Malay, 4 [2.0%] Indian, and 2 [1.0%] other ethnicities [according to Singapore’s national system of race classification]). A total of 137 patients (68.5%) experienced grade 3 to 5 toxic effects, and 131 (65.5%) required hospitalization. The area under the receiver operating characteristic curve for the CARG chemotoxicity prediction model was 0.74 (95% CI, 0.67-0.82), retaining good discrimination in the study population.Conclusions and RelevanceThis prognostic study conducted in a multiethnic Asian cohort of older adults supports the validity of the CARG predictive model in this population, predicting which older adults are at risk of chemotherapy-related toxic effects.

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The PANDA study: a randomized phase II study of first-line FOLFOX plus panitumumab versus 5FU plus panitumumab in RAS and BRAF wild-type elderly metastatic colorectal cancer patients

Cited by 19 publications

References 24 publications

Place of anti-EGFR therapy in older patients with metastatic colorectal cancer in 2020

Place of anti-EGFR therapy in older patients with metastatic colorectal cancer in 2020

Metastatic Gastroesophageal Cancer in Older Patients – Is this Patient Cohort Represented in Clinical Trials?

Use of the Cancer and Aging Research Group Predictive Model for Chemotherapy-Related Toxic Effects in a Multiethnic, Older Adult Asian Population

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