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VOTRAGE study Pazopanib in a population of “frail” elderly patients after geriatric assessment. A phase I study with geriatric criteria.

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Loïc Mourey

Citation

Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283

Authors

L. Mourey1, A. Ravaud2, L. Digue2, B. Cabarrou3, C.A. Gomez-Roca1, T. Valentin1, P. Olivier4, A. Fabre5, M. Mounier5, L. Balardy6, T. Filleron3

Author affiliations

  • 1 Medical Oncology, Institut Universitaire du Cancer de Toulouse - Oncopole, 31059 - Toulouse/FR
  • 2 Medical Oncology, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 3 Biostatistic Unit, Institut Universitaire du Cancer de Toulouse - Oncopole, 31059 - Toulouse/FR
  • 4 Pharmacology Department, CHU Toulouse, 31059 - Toulouse/FR
  • 5 Clinical research Unit, Institut Universitaire du Cancer de Toulouse - Oncopole, 31059 - Toulouse/FR
  • 6 Geriatric Medicine, CHU Toulouse Hôpital Purpan, 31059 - Toulouse/FR
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Resources

Background

Efficacy and toxicity of targeted therapies don’t seem to vary with age, but the impact of side effects in frail elderly patients (≥ 75 years-old) (EP) is a major concern for clinicians. Our study aims to explore an original method to find the maximum tolerated dose of Pazopanib (P), in a population of EP, classified as “frail” after comprehensive geriatric assessment (CGA), using a phase I methodology, integrating a geriatric criterion for DLT (2 points drop in Activity of Daily Living Score (ADL)). Pharmacokinetic and pharmacogenomic studies were planned.

Methods

Open-label, multicenter (2), non-randomized, phase 1 dose escalation clinical trial (standard 3 + 3 design) to determine MTD and DLT of P in a population of frail EP, selected after CGA. Tested dose levels of P were 400, 600 and 800 mg /day. Toxicity was assessed during the first cycle (28days). Patients received P until progression. The MTD was defined as the highest dose level for which 6 patients are treated with a maximum of one patient (∼20%) presenting a DLT. Main inclusion criteria • Age ≥ 75 • Metastatic solid cancers (kidney, lung, pancreatic-neuroendocrine, sarcoma, ovary, thyroid, bladder or breast) • “Frail” by CGA.

Results

From 11/2012 to 09/2017, 18 pts were included. Median age was of 82.5 (range 75-91). No DLT was reported at 400mg/day. There was 1 DLT (asthenia Grade 3) at 600 mg/day. At 800 mg/day, 3/6 patients experienced a DLT. Two patients had treatment interruption longer than two weeks due to side effects and one experienced a grade 3 hypertension. Diarrhea, fatigue and hypertension were the most frequently treatment related toxicity.

Conclusions

Our study used an original way to assess feasibility of an approved treatment in population of frail EP (≥ 75 years-old). The results demonstrate that it is probably deleterious to initiate a treatment with P in this vulnerable population at the approved dose level of 800mg/day. The treatment should be initiated at a lower dose (600mg/day). Our results reinforce the need to proceed to geriatric assessment in EP before initiation of cancer treatment to individualize their management.

Clinical trial identification

EudraCT: 2011-005012-29.

Legal entity responsible for the study

Institut Claudius Regaud.

Funding

Novartis.

Editorial Acknowledgement

Disclosure

L. Mourey: Honoraria, travel expenses and research funding: Novartis. All other authors have declared no conflicts of interest.

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