Intraperitoneal Cisplatin plus Intravenous Cyclophosphamide versus Intravenous Cisplatin plus Intravenous Cyclophosphamide for Stage III Ovarian Cancer

Alberts, David S.; Liu, P. Y.; Hannigan, Edward V.; O’Toole, Robert V.; Williams, Stephen D.; Young, James A.; Franklin, Ernest W.; Clarke‐Pearson, Daniel L.; Malviya, Vinay K.; DuBeshter, Brent; Adelson, Mark; Hoskins, William J.

doi:10.1056/nejm199612263352603

Cited by 1,134 publications

(659 citation statements)

References 9 publications

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“…chemotherapy was delivered in a similarly sized study by Morgan et al 51 whereas 76.8% of the planned i.p. cisplatin doses were delivered in the large cooperative group study reported by Alberts et al 19 Progression of disease was the most common reason for incomplete dosing rather than side effects in the present study.…”

Section: Cancer Gene Therapymentioning

confidence: 65%

“…chemotherapy in general. 19,50,51 Overall, 82.2% of the planned doses were delivered and this included 219 of 270 (81% ) doses on the multiple -dose /multiple -cycle regimens. By way of comparison, 84% of the planned i.p.…”

Section: Cancer Gene Therapymentioning

confidence: 99%

“…cisplatin after primary cytoreductive surgery for ovarian cancer. 19 Thus, ovarian cancer is a unique model for gene replacement strategies. 20,21 Preclinical studies in several in vivo models have shown that delivery of wild -type p53 to tumor cells can be achieved.…”

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confidence: 99%

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A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer

et al. 2002

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Purpose: To determine the safety, gene transfer, host immune response, and pharmacokinetics of a replication -deficient adenovirus encoding human, recombinant, wild -type p53 ( SCH 58500 ) delivered into the peritoneal cavity ( i.p. ) alone and sequentially in combination with platinum -based chemotherapy, of patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer containing aberrant or mutant p53. Methods: SCH 58500 was administered i.p. to three groups of patients with heavily pretreated recurrent disease. Group 1 ( n = 17 ) received a single dose of SCH 58500 escalated from 7.5Â10 10 to 7.5Â10 12 particles. Group 2 ( n = 9 ) received two or three doses of SCH 58500 given alone for one cycle, and then with chemotherapy for two cycles. The SCH 58500 dose was further escalated to 2.5Â10 13 particles / dose in group 2. A third group ( n = 15 ) received a 5 -day regimen of SCH 58500 given at 7.5Â10 13 particles / dose per day i.p. alone for cycle 1 and then with intravenous carboplatin / paclitaxel chemotherapy for cycles 2 and 3. Results: No dose -limiting toxicity resulted from the delivery of 236 / 287 ( 82.2% ) planned doses of SCH 58500. Fever, hypotension abdominal complaints, nausea, and vomiting were the most common adverse events. Vectorspecific transgene expression in tumor was documented by RT -PCR in cells from both ascitic fluid and tissue biopsies. Despite marked increases in serum adenoviral antibody titers, transgene expression was measurable in 17 of 20 samples obtained after two or three cycles of SCH 58500. Vector was detectable in peritoneal fluid by 24 hours and persisted for as long as 7 days whereas none was detected in urine or stool. There was poor correlation between CT scans and CA125 responses. CA125 responses, defined as a greater than 50% decrement in serum CA125 from baseline, were documented in 8 of 16 women who completed three cycles of the multidose regimen. Conclusion: CT scans are not a valid measure of response to i.p. SCH 58500 due to extensive adenoviral -induced inflammatory changes. Intraperitoneal SCH 58500 is safe, well tolerated, and combined with platinum -based chemotherapy can be associated with a significant reduction of serum CA125 in heavily pretreated patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.

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Section: Cancer Gene Therapymentioning

confidence: 65%

Section: Cancer Gene Therapymentioning

confidence: 99%

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A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer

et al. 2002

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“…The first study was carried out in the pre-taxane era and is of questionable significance now. [24] In the second study there was a high morbidity in the experimental arm and there was only a marginal benefit in the overall survival. [25] A third trial, GOG 172, randomized 415 patients with residual disease ≤1 cm to receive IV paclitaxel and cisplatin or IV paclitaxel followed by IP cisplatin (day 1) and paclitaxel (day 8).…”

Section: Rational For Intraperitoneal Chemotherapy For Ovarian Cancermentioning

confidence: 97%

The role of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer: A Review

Bhatt

Gléhen

2016

Indian J Surg Oncol

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Ovarian cancer is one of the leading causes of cancer related deaths in women worldwide. It is usually diagnosed in an advanced stage (Stages III and IV) when peritoneal cancer spread has already occurred. The standard treatment comprises of surgery to remove all macroscopic disease followed by systemic chemotherapy. Despite all efforts, it recurs in over 75 % of the cases, most of these recurrences being confined to the peritoneal cavity. Recurrent ovarian cancer has a poor long term outcome and is generally treated with multiple lines of systemic chemotherapy and targeted therapy. The propensity of ovarian cancer to remain confined to the peritoneal cavity warrants an aggressive locoregional approach. The combined treatment comprising of cytoreductive surgery (CRS) that removes all macroscopic disease and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) has been effective in providing long term survival in selected patients with peritoneal metastases of gastrointestinal origin. Intraperitoneal chemotherapy used as adjuvant therapy has shown a survival benefit in ovarian cancer. This has prompted the use of CRS and HIPEC in the management of ovarian cancer as a part of first line therapy and second line therapy for recurrent disease. This article reviews the current literature and evidence for the use of HIPEC in ovarian cancer.

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“…treatment regimens have been significantly superior to intravenous regimens in some randomized trials, but the efficacy of the approach has been limited by cancer cell resistance to standard chemotherapeutic agents. 3 Many potential mechanisms of resistance to standard chemotherapy have been explored. Predictors of relapse include clinical variables (eg residual tumor following debulking surgery) as well as molecular variables.…”

mentioning

confidence: 99%

Efficacy of a replication-selective adenovirus against ovarian carcinomatosis is dependent on tumor burden, viral replication and p53 status

Heise¹,

Ganly²,

Kim³

et al. 2000

Gene Ther

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Intraperitoneal Cisplatin plus Intravenous Cyclophosphamide versus Intravenous Cisplatin plus Intravenous Cyclophosphamide for Stage III Ovarian Cancer

Abstract: As compared with intravenous cisplatin, intraperitoneal cisplatin significantly improves survival and has significantly fewer toxic effects in patients with stage III ovarian cancer and residual tumor masses of 2 cm or less.

Cited by 1,134 publications

References 9 publications

A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer

A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer

The role of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer: A Review

Efficacy of a replication-selective adenovirus against ovarian carcinomatosis is dependent on tumor burden, viral replication and p53 status

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