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Long-term efficacy of crizotinib in a metastatic papillary renal carcinoma with MET amplification: a case report and literature review.

ABSTRACT: BACKGROUND:Papillary renal cell carcinoma (pRCC) is the 2nd most frequent histological type of kidney cancer and accounts for approximately 15% of all renal cell carcinoma. It has a poorer prognosis than clear cell RCC (ccRCC) with a lack of standard treatments. CASE PRESENTATION:We report the case of a 51?year old man with a metastatic pRCC (hepatic dome and left colonic peritoneal carcinomatosis) progressive after sunitinib, with a MET amplification. The patient was enrolled in the UNICANCER-sponsored AcSé crizotinib trial (NCT02034981), designed to give an access to crizotinib for patients with tumors harboring a genomic alteration on one of the biological targets of the drug. With 2nd line crizotinib (250?mg twice/day), the patient had a very good tolerance, a partial response in the target lesions using RECIST 1.1, and a 19?months' clinical efficacy. CONCLUSIONS:In metastatic pRCC with a MET amplification, crizotinib maybe a potential met-inhibitory therapeutic option.

SUBMITTER: Rochigneux P

PROVIDER: S-EPMC6251103 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Long-term efficacy of crizotinib in a metastatic papillary renal carcinoma with MET amplification: a case report and literature review.

Rochigneux Philippe P Thomassin-Piana Jeanne J Laibe Sophy S Brunelle Serge S Salem Naji N Escudier Bernard B Vassal Gilles G Gravis Gwenaelle G

BMC cancer 20181122 1

<h4>Background</h4>Papillary renal cell carcinoma (pRCC) is the 2nd most frequent histological type of kidney cancer and accounts for approximately 15% of all renal cell carcinoma. It has a poorer prognosis than clear cell RCC (ccRCC) with a lack of standard treatments.<h4>Case presentation</h4>We report the case of a 51 year old man with a metastatic pRCC (hepatic dome and left colonic peritoneal carcinomatosis) progressive after sunitinib, with a MET amplification. The patient was enrolled in ...[more]

PMID: 30466410

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Project description:ImportancePapillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group.ObjectiveTo determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib.Design, setting, and participantsThe SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened.InterventionsPatients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment.Main outcomes and measuresThe primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability.ResultsAt data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy.Conclusions and relevanceAlthough patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted.Trial registrationClinicalTrials.gov Identifier: NCT03091192.

Dataset Information

Long-term efficacy of crizotinib in a metastatic papillary renal carcinoma with MET amplification: a case report and literature review.

Publications

Long-term efficacy of crizotinib in a metastatic papillary renal carcinoma with MET amplification: a case report and literature review.

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