Sunitinib in metastatic renal cell carcinoma (mRCC): a developing country experience. Do our patients behave differently than the Western patients?

Mir, Mohmad Hussain; Changal, Khalid; Aziz, Shiekh Aejaz; Bhat, Gull Mohammad; Lone, Abdul Rashid

doi:10.1007/s11255-016-1380-2

Cited by 9 publications

(8 citation statements)

References 11 publications

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“…In our study, sorafenib treatment was associated with an astounding number of mucocutaneous side effects, especially hand-foot skin disease compared to reports from other clinical studies (21,30,34). In an Asian population, fatigue and hand-foot skin reactions were more common compared to diarrhea, which is the most common adverse effect in non-Asian populations (35).…”

Section: Discussionsupporting

confidence: 40%

Sorafenib as a Second-Line Treatment in Metastatic Renal Cell Carcinoma in Mexico: A Prospective Cohort Study

Martin-Aguilar

Núñez-López

Ramirez‐Sandoval

2020

Preprint

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Background: Sequential inhibition of the vascular endothelial growth factor (VEGF) pathway with sorafenib could be useful for patients with metastatic renal cell carcinoma (RCC). Our aim was to determine the activity and tolerability of sorafenib as a second-line therapy in advanced RCC initially treated with a different VEGF-tyrosine kinase inhibitor (TKI).Methods: A prospective observational cohort in Mexico (2012–2019). We included 148 subjects with metastatic RCC and who had progression despite treatment with sunitinib (n = 144) or pazopanib (n = 4). The primary end-point was time to disease progression as evaluated every 12–16 weeks.Results: The mean age of the cohort was 58 years (interquartile range [IQR] 48-68), 104 (70%) were men, and 51 (35%) had a favorable prognosis according to the IMDC (International Metastatic RCC Database Consortium) prognostic model. The median progression-free survival (PFS) and overall-survival after the introduction of sorafenib treatment was 8.5 months (95% confidence interval [CI]: 6.8–10.2) and 40.1 months (95% CI: 35.2–45.0) respectively. The median overall survival from RCC diagnosis to death was 71 months (95% CI: 63.9–79.4). On multivariate analyses, age >65 years was associated with a longer PFS (HR 0.57; 95% CI: 0.35-0.93; p = 0.025). The median PFS in subjects aged >65 years was longer compared to subjects ≤65 years (14.0 [95% CI: 9.2–17.9] vs. 7.2 months [95% CI: 5.5–8.9]; p = 0.018). Adverse events grade ≥3 associated with sorafenib occurred in 42 (28%) patients.Conclusion: Sequential inhibition of VEGF with sorafenib as a second-line treatment may benefit patients with metastatic RCC, especially in subjects >65 years old.

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Section: Discussionsupporting

confidence: 40%

Sorafenib as a Second-Line Treatment in Metastatic Renal Cell Carcinoma in Mexico: A Prospective Cohort Study

Martin-Aguilar

Núñez-López

Ramirez‐Sandoval

2020

Preprint

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“…Alopecia is a little discussed side effect of tyrosine kinase inhibitors (TKIs) and is usually milder than that in chemotherapy. A PubMed search carried out in November 2016 using the term (“sunitinib” [Supplementary Concept] OR “sunitinib” [All Fields]) AND (“alopecia” [MeSH Terms] OR “alopecia” [All Fields]) revealed only 13 articles [ 7 – 19 ] of which only five articles [ 7 – 11 ] analysed the adverse effect of sunitinib. Changal et al reported incidence of alopecia in 13% of patients treated with sunitinib for mRCC [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

“…A PubMed search carried out in November 2016 using the term (“sunitinib” [Supplementary Concept] OR “sunitinib” [All Fields]) AND (“alopecia” [MeSH Terms] OR “alopecia” [All Fields]) revealed only 13 articles [ 7 – 19 ] of which only five articles [ 7 – 11 ] analysed the adverse effect of sunitinib. Changal et al reported incidence of alopecia in 13% of patients treated with sunitinib for mRCC [ 7 ]. Another study from China shows alopecia in 34% of patients [ 8 ], while results from other studies by Chan and Lee show alopecia in 6 and 5% of patients respectively [ 9 , 10 ].…”

Section: Discussionmentioning

confidence: 99%

Unusual progression of renal cell carcinoma with carcinomatosis peritoneii and Krukenberg tumour and alopecia with sunitinib therapy in young female

Pandey

Mahendran

Shukla³

2018

World J Surg Onc

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BackgroundSunitinib is a multiple receptor tyrosine kinase inhibitor (TKI) used for the treatment of renal cell carcinoma (RCC). It increases the median survival considerably with minimum side effects. Alopecia is one of the rare side effects. Metastasis to the ovary is also rare. We report a case of RCC metastasizing to the ovary developing alopecia early on starting sunitinib.Case presentationA 22-year-old hypothyroid girl underwent right radical nephrectomy for T2N0 RCC. Histopathology was clear cell carcinoma. Six months later, she presented with right iliac fossa pain, imaging revealed metastasis to the ileocolic junction and the ovary, an exploratory laparotomy was carried out and, after debulking, the patient was started on sunitinib. Four weeks after the start of the treatment, she developed alopecia. She was continued with sunitinib therapy till progression.ConclusionsThe present case shows a rare metastasis to the ovary and early onset of rare adverse event of alopecia on starting sunitinib therapy. In the presence of confounding factors like hypothyroidism and dandruff, establishing this as an adverse reaction of sunitinib is difficult. This case had a unique metastatic spread with involvement of the bowel, ovary and peritoneal carcinomatosis. Use of adjuvant TKI's after resection of primary tumour in nonmetastatic setting may reduce metastatic rates and increase progression-free survival.

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“…We also made use of GRADE (Grades of Recommendations Assessment, Development and Evaluation) for evaluating therapeutic strategy and the study design regarding the survival, response rates, and toxicity. The GRADE is categorized into4 classes (high, medium, low, and very low) (17).…”

Section: Quality Evaluationmentioning

confidence: 99%

A 2/1 Sunitinib Dosing Schedule Provides Superior Antitumor Effectiveness and Less Toxicity Than a 4/2 Schedule for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis

Deng

et al. 2020

Front. Oncol.

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Background: The standard sunitinib schedule to treat metastatic renal cell carcinoma (mRCC) is 4 weeks on/2 weeks off (4/2). However, some studies revealed intolerable adverse events (AEs) in patients on this schedule. An alternative schedule, 2 weeks on/1 week off (2/1), may overcome this issue. This meta-analysis was performed to compare the effectiveness and toxicity between the 2/1 and 4/2 sunitinib dosing schedules. Methods: We acquired relevant studies by searching PubMed, ScienceDirect, the Cochrane Library, Scopus, Ovid MEDLINE, Embase, Web of Science, and Google Scholar. Our main endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and AEs. Results: We identified 9 medium-and high-quality studies. Both schedules were effective for mRCC, with comparable OS and similar ORR. However, the 2/1 schedule had better PFS (hazard ratio (HR) = 0.81, 95% confidence interval [CI]: 0.66-0.99, P = 0.04), higher DCR [risk rate (RR) = 1.22, 95% CI: 1.01-1.47, P = 0.04] and fewer dosage interruptions (RR = 0.60, 95% CI: 0.43-0.84, P = 0.003). Additionally, the 2/1 schedule elicited fewer specific severe AEs, including thrombocytopenia/platelet disorder, hand-foot syndrome, hypertension, and fatigue. In our subanalysis, PFS was better among East Asians using the 2/1 schedule than among other populations (HR= 0.75, 95% CI: 0.58-0.98, P = 0.03), and patients administered an initial dosage of 50 mg/d on the 2/1 schedule had superior PFS (HR = 0.76, 95% CI: 0.59-0.97, P = 0.03) than those others. Conclusions: These findings suggest that the 2/1 schedule is more suitable for mRCC than 4/2, due to superior PFS, better DCR and fewer AEs. Nevertheless, more large-scale studies with good quality are needed.

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Sunitinib in metastatic renal cell carcinoma (mRCC): a developing country experience. Do our patients behave differently than the Western patients?

Abstract: Non-Western patients behave differently with sunitinib therapy compared to Western patients. Our patients have more mucocutaneous side effects and lesser overall survival.

Cited by 9 publications

References 11 publications

Sorafenib as a Second-Line Treatment in Metastatic Renal Cell Carcinoma in Mexico: A Prospective Cohort Study

Sorafenib as a Second-Line Treatment in Metastatic Renal Cell Carcinoma in Mexico: A Prospective Cohort Study

Unusual progression of renal cell carcinoma with carcinomatosis peritoneii and Krukenberg tumour and alopecia with sunitinib therapy in young female

A 2/1 Sunitinib Dosing Schedule Provides Superior Antitumor Effectiveness and Less Toxicity Than a 4/2 Schedule for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis

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