Primary Peritoneal Cancer Treatment Protocols 

Primary Peritoneal Cancer Treatment Protocols 

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Treatment protocols for primary peritoneal cancer are provided below. Because of the disseminated nature of the disease, primary peritoneal cancer is treated with surgical debulking and chemotherapy. Women with any stage of primary peritoneal cancer should be considered for a clinical trial.

Patients who have undergone optimal tumor debulking should be offered intraperitoneal (IP) chemotherapy; the following dosing regimen is recommended [1, 2, 3] :

Paclitaxel 135 mg/m2 IV infused over 24 h on day 1 (may give over 3 h if tolerated) plus cisplatin 100 mg/m2 IP on day 2 (may reduce cisplatin to 75 mg/m2 and give on day 1 or day 2 to allow for an outpatient regimen) plus  paclitaxel 60 mg/m2 IP on day 8

Administer every 21 d for six cycles

One of the IV regimens should be considered under any of the following circumstances:

The patient is unable to tolerate IP chemotherapy

The disease has been suboptimally debulked (ie, disease > 1 cm)

The disease has spread to the liver parenchyma

The patient has malignant pleural effusions

In the treatment recommendations below, note that carboplatin is dosed to achieve a targeted area under the concentration curve (AUC). AUC is the target area under the concentration versus time curve in mg/mL/min. The calculation is based on the Calvert formula, [4] [see the Carboplatin AUC Dose Calculation (Calvert formula) calculator]; the maximum dose is based on a maximum estimated glomerular filtration rate (GFR).

Recommendations are as follows:

Paclitaxel 135-175 mg/m2 IV infused over 3 h plus carboplatin AUC 5-7.5 IV infused over 30-60 min every 21 d for three to six cycles [3, 5] or

Docetaxel 60-75 mg/m2 IV infused over 1 h plus  carboplatin AUC 5-6 IV infused over 1 h every 21 d for three to six cycles [6]

Platinum-sensitive disease:

A disease-free interval of at least 6 months constitutes platinum-sensitive disease; in such cases, patients have been re-treated with platinum-based chemotherapy; most patients are re-treated with a platinum doublet. Recommendations are as follows:

Paclitaxel 135-175 mg/m2 IV infused over 3 h plus  carboplatin AUC 5-6 IV infused over 1 h every 21 d for six cycles [5] or

Docetaxel 60-75 mg/m2 IV infused over 1 h plus  carboplatin AUC 5 IV infused over 1 h every 21 d for three to six cycles [6] or

Pegylated liposomal doxorubicin 30 mg/m2 IV infused over 30 min plus  carboplatin AUC 5 IV every 21 d for six cycles [7] or

Gemcitabine 1000 mg/m2 IV on days 1 and 8 plus  carboplatin AUC 4 on day 1 every 21 d for six cycles [8] or

Carboplatin AUC 2 IV push with paclitaxel 80 mg/m2 IV infused over 3 h on days 1, 8, and 15 [9]

Consideration may be given to bevacizumab, in combination with carboplatin and paclitaxel [21] or with carboplatin and gemcitabine [10] , followed by bevacizumab alone, as follows:

Platinum-resistant disease:

Single-agent treatment is the preferred approach for patients with platinum-resistant disease or for patients with intermediate platinum-sensitive disease with a short time to recurrence of 6-12 months. Recurrence that occurs less than 6 months after completion of initial therapy can be considered for single-agent treatment, such as the following:

Pegylated liposomal doxorubicin 50 mg/m2 IV infused over 30 min every 21 d [11, 12] or

Topotecan 1.25 mg/m2 IV infused over 30 min on days 1-5 every 21 d [11] or

Gemcitabine 1000 mg/m2 IV infused over 30 min on days 1 and 8 every 21 d [13] or

Other agents listed in the National Comprehensive Cancer Network (NCCN) Compendium [14]

In November 2014, the FDA approved bevacizumab (Avastin) for platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or peritoneal cancers in patients who received no more than two prior chemotherapy regimens. It is indicated in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan.

Approval was based on results from the Phase III AURELIA study, which showed that adding bevacizumab to chemotherapy significantly improved progressive-free survival (PFS) and overall response rate (ORR). Median PFS was 3.4 months with chemotherapy alone versus 6.7 months with bevacizumab-containing therapy. ORR was 11.8% versus 27.3%, respectively (P = 0.001). The addition of bevicizumab showed a slight trend toward improving overall survival (OS) compared with chemotherapy alone, but it was not significant. The OS hazard ratio was 0.85 (95% confidence index [CI], 0.66 to 1.08; P < 0.174; median OS, 16.6 v 13.3 months, respectively). [15]

Combination regimens with bevacizumab include the following:

Bevacizumab 10 mg/kg IV every 14 d in combination with one of the following IV chemotherapy regimens: paclitaxel, pegylated liposomal doxorubicin, or topotecan (topotecan is given weekly) [15] or

Bevacizumab 15 mg/kg IV every 21 d in combination with topotecan (every 21 d) [15]

Secondary cytoreductive surgery:

The role of cytoreductive surgery continues to be explored in patients with recurrent disease; if more than 6 months have passed since complete clinical response to therapy, reoperation can be considered. [16]

The AUC for treatment of fallopian tube cancers ranges from 5-7.5; it may be reduced to an AUC of 4 in patients with limited functional status or patients who have had prior treatment with chemotherapy and radiation. [17]

Antiangiogenic agents (eg, bevacizumab) may be beneficial as front-line therapy, as maintenance therapy, or in cases of recurrent disease, and they are being explored in ongoing studies. [18, 10]

Neoadjuvant chemotherapy may be appropriate in patients who are unable to tolerate up-front debulking. [19]

The use of weekly paclitaxel is being studied in regimens such as the following: [20]

Weekly carboplatin AUC 6 IV push once every 3 wk plus  paclitaxel 80 mg/m2 IV infused over 3 h every week

Armstrong DK, Bundy B, Wenzel L, et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5. 354(1):34-43. [Medline].

Walker JL. Intraperitoneal chemotherapy for ovarian cancer: 2009 goals. Gynecol Oncol. 2009 Mar. 112(3):439-40. [Medline].

Konner JA, Grabon DM, Gerst SR, et al. Phase II study of intraperitoneal paclitaxel plus cisplatin and intravenous paclitaxel plus bevacizumab as adjuvant treatment of optimal stage II/III epithelial ovarian cancer. J Clin Oncol. 2011 Dec 10. 29(35):4662-8. [Medline].

Calvert AH, Newell DR, Gumbrell LA, O’Reilly S, Burnell M, Boxall FE, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov. 7(11):1748-56. [Medline].

Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1. 21(17):3194-200. [Medline].

Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, et al. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17. 96(22):1682-91. [Medline].

A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months). NCT00189553. Available at http://clinicaltrials.gov/ct2/show/NCT00189553.

Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10. 24(29):4699-707. [Medline].

Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21. 361(9375):2099-106. [Medline].

Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct. 139 (1):10-6. [Medline]. [Full Text].

Gordon AN, Tonda M, sun S, Rackoff W. Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004. 95:1-8.

Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol. 2011 Sep 20. 29(27):3628-35. [Medline].

Markman M, Webster K, Zanotti K, Kulp B, Peterson G, Belinson J. Phase 2 trial of single-agent gemcitabine in platinum-paclitaxel refractory ovarian cancer. Gynecol Oncol. 2003 Sep. 90(3):593-6. [Medline].

National Comprehensive Cancer Network (NCCN) guidelines. Available at http://www.nccn.org/. Accessed: November 20, 2014.

Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1. 32(13):1302-8. [Medline].

Chi DS, McCaughty K, Diaz JP, Huh J, Schwabenbauer S, Hummer AJ, et al. Guidelines and selection criteria for secondary cytoreductive surgery in patients with recurrent, platinum-sensitive epithelial ovarian carcinoma. Cancer. 2006 May 1. 106(9):1933-9. [Medline].

Fader AN, von Gruenigen V, Gibbons H, Abushahin F, Starks D, Markman M, et al. Improved tolerance of primary chemotherapy with reduced-dose carboplatin and paclitaxel in elderly ovarian cancer patients. Gynecol Oncol. 2008 Apr. 109(1):33-8. [Medline].

Burger RA, Brady MF, Bookman MA, et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): a Gynecologic Oncology Group study. J Clin Oncol. 2010. 28(18 suppl):

Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, et al. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2. 363(10):943-53. [Medline].

Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, et al. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17. 374(9698):1331-8. [Medline].

Coleman RL, Brady RF, Herzog TJ, et al. A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer. Presented at: Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer 2015; March 28-31, 2015; Chicago, IL. Abstract 3.

from Memorial Sloan-Kettering – Elizabeth L Jewell, MD, MHSc Assistant Member, Department of Surgery, Division of Gynecology, Memorial Sloan-Kettering Cancer Center; Assistant Attending Surgeon, Department of Surgery, Division of Gynecology, Memorial Hospital for Cancer and Allied Diseases; Assistant Professor, Department of Obstetrics and Gynecology, Weill Cornell Medical College

from Memorial Sloan-Kettering – Elizabeth L Jewell, MD, MHSc is a member of the following medical societies: Alpha Omega Alpha, American College of Obstetricians and Gynecologists, Society of Gynecologic Oncology

Disclosure: Nothing to disclose.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee

Christopher D Braden, DO is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology

Disclosure: Nothing to disclose.

from Memorial Sloan-Kettering – Yukio Sonoda, MD Associate Professor, Weill Cornell Medical College; Associate Attending Surgeon, Gynecology Service, Department of Surgery, Memorial Hospital for Cancer and Allied Diseases; Associate Member, Memorial Sloan-Kettering Cancer Center

from Memorial Sloan-Kettering – Yukio Sonoda, MD is a member of the following medical societies: American College of Obstetricians and Gynecologists, American College of Surgeons, American Medical Association, Society of Gynecologic Oncology, Society of Laparoendoscopic Surgeons, AAGL, American Society of Clinical Oncology, International Gynecologic Cancer Society, Japanese Medical Society of America, Korean American Medical Assocation

Disclosure: Nothing to disclose.

Primary Peritoneal Cancer Treatment Protocols 

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