Meeting
2017 Gastrointestinal Cancers Symposium
Pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) in patients with gastric cancer and peritoneal metastasis (PIPAC-GA1).
Authors
Florian Struller
Dept. of Surgery, University of Tubingen, Tubingen, Germany
Florian Struller , Philipp Horvath , Wiebke Solass , Frank Jurgen Weinreich , Alfred Konigsrainer , Marc A Reymond
Organizations
Dept. of Surgery, University of Tubingen, Tubingen, Germany, Dept. of Surgery, University of Tuebingen, Tubingen, Germany, Medical School Hanover, Hannover, Germany, University of Tuebingen, Tuebingen, Germany, University of Tubingen, Tubingen, Germany
Research Funding
Other
Background: Efficacy of 2nd and 3rdline chemotherapy in recurrent gastric cancer with peritoneal metastasis (RGCPM) is limited. We assessed the feasibility, safety and activity of intraperitoneal chemotherapy as PIPAC C/D in RGCPM after > 1 line of intravenous chemotherapy. Methods: Open-label, single-arm, Phase II ICH-GCP Clinical Trial (NCT01854255) Patients were scheduled for 3 courses q42 days of low-dose PIPAC with doxorubicin 1.5 mg/m2 and cisplatin 7.5 mg/m2. Primary endpoint was objective tumor response (RECIST 1.1). Secondary endpoints were safety (CTCAE 4.0), histological tumor regression (PRGS) and overall survival. Results: 25 patients were enrolled. 10/25 (40 %, ITT) patients had an OTR. Complete or major regression on histology was observed in 9/12 (75 %) patients who underwent at least 2 PIPAC cycles. Mean overall survival was 8.4 months (13.1 months in patients with PCI < 12). There were no treatment-related deaths, no grade 4 toxicity and four (16%) grade 3 toxicities. Conclusions: PIPAC C/D is well tolerated and active in patients with RGCPM. Survival is encouraging. Randomized controlled trials should now be designed. Clinical trial information: NCT01854255
| Value | % | |
|---|---|---|
| Number of patients | 25 | |
| Age | 55.1 ± 13.0 | |
| Sex (M:W) | 10 : 15 | 40% : 60% |
| Karnofksy Index (%) | 81 ± 11 | |
| Peritoneal Carcinomatosis Index (PCI) | ||
| ≤ 12 | 8 | 32% |
| > 12 | 17 | 68% |
| Histology | ||
| - signet-ring | 22 | 88% |
| - intestinal | 3 | 12% |
| Ascites (ml) | ||
| ≤ 300 | 18 | 72% |
| > 300 | 7 | 28% |
| Previous chemotherapy lines | ||
| - 1 | 16 | 64% |
| - 2 | 5 | 20% |
| - 3 | 2 | 8% |
| - 4 | 2 | 8% |
| Previous surgery | ||
| - Gastrectomy | 15 | 60% |
| Previous radiotherapy | 3 | 12% |
| Number of PIPAC cycles (n = 43) | ||
| - 1 | 25 | 100% |
| - 2 | 12 | 48% |
| - 3 | 6 | 24% |
| Adverse events (CTCAE Grade)* | ||
| - 1 | 26 | > 100% |
| - 2 | 6 | 24% |
| - 3 | 4 | 16% |
| - 4 | 0 | 0% |
| - 5 | 0 | 0% |
| Objective Tumor Response, n = 13 (PP) or n = 25 (ITT) | PP / ITT | |
| - CR | 1 | 8% / 4% |
| - PR | 2 | 15% / 8% |
| - SD | 7 | 54% / 28% |
| - PD | 3 | 23% / 12% |
| - Not available | 12 | 0% / 48% |
| Histological response (PRGS), n = 12 (PP) or n = 25 (ITT) | PP / ITT | |
| - Complete response | 1 | 8% / 4% |
| - Major response | 8 | 67% / 32% |
| - Minor or no response | 3 | 25% / 12% |
| - Not eligible | 13 | 0% / 48% |
| Survival (months) | ||
| - all patients | 8.4 ± 1.7 | |
| - PCI ≤ 12 | 13.1 ± 3.5 | |
| - PCI > 12 | 5.9 ± 1.2 |
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A: Cancers of the Esophagus and Stomach
Track
Cancers of the Esophagus and Stomach
Sub Track
Multidisciplinary Treatment
Clinical Trial Registration Number
NCT01854255
Citation
J Clin Oncol 35, 2017 (suppl 4S; abstract 99)
DOI
10.1200/JCO.2017.35.4_suppl.99
Abstract #
99
Poster Bd #
H11
Abstract Disclosures
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