A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254)

John K. Chan, William Brady, Bradley J. Monk, Jubilee Brown, Mark S. Shahin, Peter G. Rose, Jae Hoon Kim, Angeles Alvarez Secord, Joan L. Walker, David M. Gershenson

Research output: Contribution to journalArticle

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Abstract

Objectives: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. Methods: All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20% or 6-month PFS of at least 25%. Results: Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83%) were White, 4 (13%) Asian, and 1 (3%) unknown. The majority 28 (83%) patients, underwent ≤3 but 2 (7%) had 16 courses of study therapy. Five (16.7%) patients had PFS ≥6 months (90% CI: 6.8%–31.9%). Two (6.7%) patients had a partial or complete response (90% CI: 1.2%–19.5%). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Conclusion: Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma. ClinicalTrials.gov number, NCT00979992.

Original languageEnglish
Pages (from-to)247-252
Number of pages6
JournalGynecologic Oncology
Volume150
Issue number2
DOIs
Publication statusPublished - 2018 Aug

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Carcinoma
Disease-Free Survival
Anemia
Therapeutics
Antigen Receptors
Leukopenia
Neutropenia
Acute Kidney Injury
Thrombocytopenia
Estrogen Receptors
Ovarian Neoplasms
Abdominal Pain
Fatigue
Disease Progression
sunitinib
Hypersensitivity
Immunohistochemistry
Stroke
Hypertension
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Obstetrics and Gynaecology

Cite this

Chan, John K. ; Brady, William ; Monk, Bradley J. ; Brown, Jubilee ; Shahin, Mark S. ; Rose, Peter G. ; Kim, Jae Hoon ; Secord, Angeles Alvarez ; Walker, Joan L. ; Gershenson, David M. / A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma : An NRG Oncology/Gynecologic Oncology Group Study (GOG-254). In: Gynecologic Oncology. 2018 ; Vol. 150, No. 2. pp. 247-252.
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title = "A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254)",
abstract = "Objectives: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. Methods: All patients had one or two prior regimens with measurable disease. Tumors were at least 50{\%} clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20{\%} or 6-month PFS of at least 25{\%}. Results: Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83{\%}) were White, 4 (13{\%}) Asian, and 1 (3{\%}) unknown. The majority 28 (83{\%}) patients, underwent ≤3 but 2 (7{\%}) had 16 courses of study therapy. Five (16.7{\%}) patients had PFS ≥6 months (90{\%} CI: 6.8{\%}–31.9{\%}). Two (6.7{\%}) patients had a partial or complete response (90{\%} CI: 1.2{\%}–19.5{\%}). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Conclusion: Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma. ClinicalTrials.gov number, NCT00979992.",
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A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma : An NRG Oncology/Gynecologic Oncology Group Study (GOG-254). / Chan, John K.; Brady, William; Monk, Bradley J.; Brown, Jubilee; Shahin, Mark S.; Rose, Peter G.; Kim, Jae Hoon; Secord, Angeles Alvarez; Walker, Joan L.; Gershenson, David M.

In: Gynecologic Oncology, Vol. 150, No. 2, 08.2018, p. 247-252.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma

T2 - An NRG Oncology/Gynecologic Oncology Group Study (GOG-254)

AU - Chan, John K.

AU - Brady, William

AU - Monk, Bradley J.

AU - Brown, Jubilee

AU - Shahin, Mark S.

AU - Rose, Peter G.

AU - Kim, Jae Hoon

AU - Secord, Angeles Alvarez

AU - Walker, Joan L.

AU - Gershenson, David M.

PY - 2018/8

Y1 - 2018/8

N2 - Objectives: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. Methods: All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20% or 6-month PFS of at least 25%. Results: Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83%) were White, 4 (13%) Asian, and 1 (3%) unknown. The majority 28 (83%) patients, underwent ≤3 but 2 (7%) had 16 courses of study therapy. Five (16.7%) patients had PFS ≥6 months (90% CI: 6.8%–31.9%). Two (6.7%) patients had a partial or complete response (90% CI: 1.2%–19.5%). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Conclusion: Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma. ClinicalTrials.gov number, NCT00979992.

AB - Objectives: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. Methods: All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20% or 6-month PFS of at least 25%. Results: Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83%) were White, 4 (13%) Asian, and 1 (3%) unknown. The majority 28 (83%) patients, underwent ≤3 but 2 (7%) had 16 courses of study therapy. Five (16.7%) patients had PFS ≥6 months (90% CI: 6.8%–31.9%). Two (6.7%) patients had a partial or complete response (90% CI: 1.2%–19.5%). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Conclusion: Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma. ClinicalTrials.gov number, NCT00979992.

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