Phase I trial of intraperitoneal taxol: a Gynecoloic Oncology Group study.

Markman, Maurie; Rowinsky, Eric K.; Hakes, Thomas B.; Reichman, Bonnie; Jones, Walter B.; Lewis, Joanne; Rubin, Stephen C.; Curtin, John P.; Barakat, Richard R.; Phillips, M.

doi:10.1200/jco.1992.10.9.1485

Cited by 297 publications

(160 citation statements)

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“…The large molecular weight and bulky chemical structure of paclitaxel delay its peritoneal clearance [10] and increase exposure in the peritoneal cavity, and thus it can be exploited in the treatment of gastric cancer with peritoneal dissemination.…”

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confidence: 99%

Intraperitoneal administration of paclitaxel and oral S-1 for a patient with peritoneal dissemination and hydronephrosis due to advanced gastric cancer

et al. 2007

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S-1 has been developed in Japan as an oral anticancer drug, composed of tegafur, 5-chloro-2, 4-dihydroxypyridine (gimeracil), and monopotassium 1, 2, 3, 4-tetrahydro-2, 4-dioxo-1, 3, 5-triazine-6-carboxylate (oteracil), based on the biological modulation of 5-fl uorouracil (FU) [5]. Japanese late phase II trials of S-1 in gastric cancer have shown overall response rates of up to 49% and a median survival period of 8 months [6,7]. We have demonstrated that S-1 has a larger area under the curve 5-FU for peritoneal dissemination and ascites than for plasma [8], and thus S-1 might be effective for prolonging the survival of gastric cancer patients with peritoneal metastasis.Paclitaxel is a cytotoxic antineoplastic agent that results in tumor cell death by causing the excessive polymerization of tubulin and microtubule dysfunction [9]. The large molecular weight and bulky chemical structure of paclitaxel delay its peritoneal clearance [10] and increase exposure in the peritoneal cavity, and thus it can be exploited in the treatment of gastric cancer with peritoneal dissemination.We report a gastric cancer patient with peritoneal dissemination and hydronephrosis who was successfully treated with intraperitoneal infusion of paclitaxel and oral administration of S-1. Case reportA 34-year-old man was treated with an H2-blocker antagonist for about 6 months for a chief complaint of upper abdominal discomfort, suggesting the possibility of duodenal ulcer. Because his condition did not improve, he underwent endoscopic examination at another clinic. He was diagnosed as having type 3 advanced gastric cancer on the greater curvature of the gastric body by upper gastrointestinal (UGI) and endoscopic examination. He was referred to a hospital for surgical resection. An abdominal computed tomogra- AbstractWe report a patient with type 3 gastric cancer with peritoneal dissemination and hydronephrosis who was successfully treated with intraperitoneal infusion of paclitaxel and oral administration of S-1. He was diagnosed with unresectable gastric cancer with severe peritoneal dissemination by staging laparoscopy. We selected combined chemotherapy with both paclitaxel and S-1. Paclitaxel at 60 mg/m 2 was administered intraperitoneally on days 1 and 8, and S-1 at 100 mg/body was administered orally for 14 days, followed by 7 days' rest, as one course. After fi ve courses, primary tumor reduction was confi rmed and no cancer cells were detected on pathocytological investigation at second-look laparoscopy. The patient underwent total gastrectomy with lymph node dissection. He died from liver metastasis 29 months after the initial treatment, but he had not suffered from peritoneal metastases and had kept a good quality of life (QOL) since that treatment. This chemotherapy can be applied as one of the promising candidates for the treatment of patients with peritoneal metastasis of gastric cancer.

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Intraperitoneal administration of paclitaxel and oral S-1 for a patient with peritoneal dissemination and hydronephrosis due to advanced gastric cancer

et al. 2007

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“…Thus, the large saline fluid volume used to administer intraperitoneal chemotherapy not only assures drug distribution throughout the intraperitoneal space, but also retards drug clearance to make a drug more available to intraperitoneal tumor deposits. Finally, as documented by Howell et al and Casper et al [4,5] with intraperitoneal cisplatin, and by Markman et al and Francis, et al [8,9] with intraperitoneal paclitaxel, large systemic plasma concentration • time products of intraperitoneal administered drugs can be achieved in the absence of relatively low peak plasma concentrations. As a result of the latter phenomenon, IP administered cisplatin is associated with considerably less tinnitus, hearing loss and neutropenia than the same doses administered intravenously [10].…”

Section: Introductionmentioning

confidence: 84%

“…Intraperitoneal [9] chemotherapy can be an intimidating procedure for both patients and nurses. With a good review of the procedures and guidelines, it can be an enjoyable and rewarding experience for everyone involved.…”

Section: Nursing Perspectivesmentioning

confidence: 99%

“…• IP chemotherapy treats both intraperitoneal tumor bed and extraperitoneal tumor through systemic recirculation (1,4,5,8,9) • IP chemotherapy achieves dose intensification in the intraperitoneal space of 20-1,000 fold that achieved with "high-dose" intravenous chemotherapy regimens (4,5,8,9) • IP chemotherapy reaches intraperitoneal sites that may not be reached by the intravenous route, especially when up to 2 L of dialysate are administered…”

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Proceedings of a GOG workshop on intraperitoneal therapy for ovarian cancer

Alberts

Markman²,

Fm³

et al. 2006

Gynecologic Oncology

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Ovarian cancer is the leading cause of gynecologic cancer deaths in the U.S. The concept of intraperitoneal drug delivery for therapy of intraperitoneal cancers, such as ovarian cancer, arose in the 1960s. The field of intraperitoneal cisplatin therapy for ovarian cancer was initiated in the late 1970s and early 1980s. The markedly improved survival data resulting from a third phase III trial of intraperitoneal cisplatin for ovarian cancer in early 2006 led to an NCI Clinical Announcement and a Gynecologic Oncology Group-sponsored workshop on Intraperitoneal Therapy in January, 2006, in San Diego, California. The proceedings of this workshop summarize both research trial results and practical implementation issues associated with intraperitoneal therapy discussed at this workshop.

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“…Such a pharmacokinetic advantage for peritoneal cavity exposure is favored by high molecular weight, water solubility, high solution volume, and easy ionization. The pharmacokinetic advantage has been reported to range from 10-fold for cisplatin [39] and carboplatin [40], to as high as 1000-fold for paclitaxel [41]. Because MMC, which is commonly used intraperitoneally, is rapidly absorbed through capillary walls in the subperitoneum due to its low solubility in water, MMC has only a 20 -30-fold pharmacokinetic advantage and disappears from the blood within 3 hours [42].…”

Section: Pharmacokinetics and Local Toxicitymentioning

confidence: 99%

Intraperitoneal Chemotherapy as a Multimodal Treatment for Gastric Cancer Patients with Peritoneal Metastasis

Fushida¹,

Oyama²,

Koyama³

et al. 2013

JCT

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Peritoneal metastasis of gastric cancer is mainly caused by the dispersion of free cancer cells from the serosal surface of the invaded stomach, from surgically transected lymphatic channels, and from tumor cell-containing blood from the primary lesion into the peritoneal cavity. Intraperitoneal chemotherapy (IPC) combined with surgery has performed for the prevention and treatment of peritoneal metastasis in gastric cancer. The efficacy of this technique is influenced by the pharmacokinetic advantage achievable with the anticancer drug, timing of administration, combination with hyperthermia, and tumor volume. The pharmacokinetic advantage for peritoneal cavity exposure relative to peripheral circulation by intraperitoneal delivery for drugs including cisplatin (10-fold advantage), mitomycin C (20-to 30-fold advantage), docetaxel (500-fold advantage), and paclitaxel (1000-fold advantage) has been confirmed. To avoid uneven drug distribution in the peritoneal cavity and the re-growth of residual tumor, it seems to be reasonable to perform IPC perioperatively; however, early perioperative intraperitoneal chemotherapy (EPIC) has a relatively high morbidity rate compared with intraoperative IPC. Hyperthermia has both cytotoxicity of itself and a synergistic effect with anticancer drugs, especially mitomycin C. In the adjuvant setting, patients with either hyperthermic intraperitoneal chemotherapy (HIPEC) or EPIC showed a significant improvement of survival compared to those with surgery alone. In addition, extensive intraoperative peritoneal lavage (EIPL) seems also to be a reasonable method to reduce free cancer cells in the peritoneal cavity. For the treatment of peritoneal metastasis, cytoreductive surgery which achieves R0 or R1 resection followed by IPC has demonstrated a survival benefit, whereas gross residual tumor (R2) treated by IPC has shown poor prognosis. Extensive cytoreductive surgery, such as peritonectomy, followed by IPC achieved long-term survival for selected patients, though this aggressive procedure led to high morbidity and mortality rates. It seems that combined chemotherapy (systemically and intraperitoneally) followed by conversion surgery can be expected to be a powerful procedure for the patients with gross peritoneal tumors.

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Phase I trial of intraperitoneal taxol: a Gynecoloic Oncology Group study.

Abstract: Taxol can be delivered by the IP route with both an acceptable toxicity profile and a major pharmacokinetic advantage for cavity exposure.

Cited by 297 publications

References 7 publications

Intraperitoneal administration of paclitaxel and oral S-1 for a patient with peritoneal dissemination and hydronephrosis due to advanced gastric cancer

Intraperitoneal administration of paclitaxel and oral S-1 for a patient with peritoneal dissemination and hydronephrosis due to advanced gastric cancer

Proceedings of a GOG workshop on intraperitoneal therapy for ovarian cancer

Intraperitoneal Chemotherapy as a Multimodal Treatment for Gastric Cancer Patients with Peritoneal Metastasis

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