OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer

被引：48

作者：

Provencher, D. M. ^{[1
]}

Gallagher, C. J. ^{[2
]}

Parulekar, W. R. ^{[3
]}

Ledermann, J. A. ^{[4
]}

Armstrong, D. K. ^{[5
]}

Brundage, M. ^{[6
]}

Gourley, C. ^{[7
]}

Romero, I. ^{[8
]}

Gonzalez-Martin, A. ^{[9
]}

Feeney, M. ^{[4
]}

Bessette, P. ^{[10
]}

Hall, M. ^{[11
]}

Weberpals, J. I. ^{[12
]}

Hall, G. ^{[13
]}

Lau, S. K. ^{[14
]}

Gauthier, P. ^{[10
]}

Fung-Kee-Fung, M. ^{[12
]}

Eisenhauer, E. A. ^{[3
]}

Winch, C. ^{[3
]}

Tu, D. ^{[3
]}

MacKay, H. J. ^{[15
]}

机构：

[1] Ctr Hosp Univ Montreal, Ctr Rech, Inst Canc Montreal, Montreal, PQ, Canada

[2] Barts Hlth NHS Trust, London, England

[3] Queens Univ, CCTG, Kingston, ON, Canada

[4] UCL, Inst Canc, London, England

[5] Johns Hopkins Univ, Sch Med, Baltimore, MD USA

[6] Canc Ctr Southeastern Ontario, Kingston, ON, Canada

[7] Univ Edinburgh, Edinburgh Canc Res UK Ctr, MRC Inst Genet & Mol Med, Edinburgh, Midlothian, Scotland

[8] Inst Valenciano Oncol, Secretaria Area Clin Oncol Ginecol, Valencia, Spain

[9] MD Anderson Canc Ctr, Madrid, Spain

[10] Ctr Hosp Univ Montreal, Div Gynecol Oncol, Sherbrooke, PQ, Canada

[11] Mt Vernon Canc Ctr, Dept Obstet & Gynaecol, Northwood, Middx, England

[12] Ottawa Hosp, Div Gynaecol Oncol, Ottawa, ON, Canada

[13] St James Univ Hosp, Leeds Inst Canc & Pathol, Leeds, W Yorkshire, England

[14] McGill Univ, SMBD Jewish Gen Hosp, Div Gynecol Oncol, Segal Canc Ctr, Montreal, PQ, Canada

[15] Sunnybrook Hlth Sci Ctr, Div Hematol & Med Oncol, Odette Canc Ctr, 2075 Bayview Ave, Toronto, ON M4N 3M5, Canada

来源：

ANNALS OF ONCOLOGY | 2018年 / 29卷 / 02期

关键词：

i.p; chemotherapy; ovarian cancer; neoadjuvant; QUALITY-OF-LIFE; CLINICAL-TRIALS-GROUP; ONCOLOGY-GROUP; CISPLATIN; PACLITAXEL; QUESTIONNAIRE; CARCINOMA;

D O I：

10.1093/annonc/mdx754

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). Patients and methods: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1 cm) debulking surgery were randomized to one of the three treatment arms: (i)i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i. v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL). Results: Between 2009 and 2015, 275 patients were randomized; i. p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i. v. carboplatin/paclitaxel (n = 101) with i. p. carboplatin, i. v./i. p. paclitaxel (n = 102). The intention to treat PD9 was lower in the i. p. carboplatin arm compared with the i. v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P = 0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P = 0.27 and OS HR 0.80 (95% CI 0.47-1.35) P = 0.40. The i. p. carboplatin-based regimen was well tolerated with no reduction in QOL or increase in toxicity compared with i. v. administration alone. Conclusion: In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, i.p. carboplatin-based chemotherapy is well tolerated and associated with an improved PD9 compared with i.v. carboplatin-based chemotherapy.

引用

页码：431 / 438

页数：8

共 21 条

[21] Use and Effectiveness of Intraperitoneal Chemotherapy for Treatment of Ovarian Cancer
Wright, Alexi A.
Cronin, Angel
Milne, Dana E.
Bookman, Michael A.
Burger, Robert A.
Cohn, David E.
Cristea, Mihaela C.
Griggs, Jennifer J.
Keating, Nancy L.
Levenback, Charles F.
Mantia-Smaldone, Gina
Matulonis, Ursula A.
Meyer, Larissa A.
Niland, Joyce C.
Weeks, Jane C.
O'Malley, David M.
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (26) : 2841 - +

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