Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies

Hai-Tao Wu, Xiao-Jun Yang, Chao-Qun Huang, Jian-Hua Sun, Zhong-He Ji, Kai-Wen Peng, Qian Zhang, Yan Li, Hai-Tao Wu, Xiao-Jun Yang, Chao-Qun Huang, Jian-Hua Sun, Zhong-He Ji, Kai-Wen Peng, Qian Zhang, Yan Li

Abstract

Background: This work was to evaluate the perioperative safety and efficacy of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) with lobaplatin and docetaxel in patients with peritoneal carcinomatosis (PC) from gastrointestinal and gynecological cancers.

Methods: Patients were treated by CRS + HIPEC with lobaplatin 50 mg/m(2) and docetaxel 60 mg/m(2) in 6000 mL of normal saline at 43 ± 0.5 °C for 60 min. Vital signs were recorded for 6 days after CRS + HIPEC procedures. Perioperative serious adverse events (SAE), hematological, hepatic, renal, and electrolytes parameters, the changes in serum tumor markers (TM) before and after operation, patient recovery, and overall survival (OS) were analyzed.

Results: One hundred consecutive PC patients underwent 105 CRS + HIPEC procedures and postoperative chemotherapy. The median CRS + HIPEC duration was 463 (range, 245-820) min, and the highest temperature and heart rate during six postoperative days were 38.6 °C (median 37.5 °C) and 124 bpm (median 100 bpm), respectively. The 30-day perioperative SAE occurred in 16 (15.2 %) and mortality occurred in 2 (1.9 %) patients. Most routine blood laboratory tests at 1 week after surgery turned normal. Among 82 cases with increased preoperative TM CEA, CA125, and CA199, 71 cases had TM levels reduced or turned normal. Median time to nasogastric tube removal was 5 (range, 3-23) days, to liquid food intake 6 (range, 4-24) days, and to abdominal suture removal 15 (range, 10-30) days. At the median follow-up of 19.7 (range, 7.5-89.2) months, the median OS was 24.2 (95 % CI, 15.0-33.4) months, and the 1-, 3-, and 5-year OS rates were 77.5, 32.5, and 19.8 %, respectively. Univariate analysis identified five independent prognostic factors on OS: the origin of PC, peritoneal cancer index, completeness of CRS, cycles of adjuvant chemotherapy, and SAE.

Conclusions: CRS + HIPEC with lobaplatin and docetaxel to treat PC is a feasible procedure with acceptable safety and can prolong the survival in selected patients with PC.

Trial registration: ClinicalTrials.gov, NCT00454519.

Keywords: Cytoreductive surgery; Docetaxel; Hyperthermic intraperitoneal chemotherapy; Lobaplatin; Peritoneal carcinomatosis.

Figures

Fig. 1
Fig. 1
The Kaplan-Meier OS curves for the whole patients treated by CRS + HIPEC (a), and comparisons of OS among different primary diseases (b). mo months, OC ovarian cancer, PPC primary peritoneum carcinomatosis, GC gastric cancer, CRC colorectal cancer, PMP pseudomyxoma peritonei, CRS cytoreductive surgery, HIPEC hyperthermic intraperitoneal chemotherapy
Fig. 2
Fig. 2
Kaplan-Meier survival curves. The statistical significance in overall survival (OS) comparisons stratified by PCI (a), CC (b), postoperative adjuvant chemotherapy (c), and SAE (d). mo months, PCI peritoneal cancer index, CC completeness of cytoreduction, SAE serious adverse events

References

    1. Stewart JH, Shen P, Levine EA. Intraperitoneal hyperthermic chemotherapy for peritoneal surface malignancy: current status and future directions. Ann Surg Oncol. 2005;12(10):765–77. doi: 10.1245/ASO.2005.12.001.
    1. Chua TC, Esquivel J, Pelz JO, Morris DL. Summary of current therapeutic options for peritoneal metastases from colorectal cancer. J Surg Oncol. 2013;107(6):566–73. doi: 10.1002/jso.23189.
    1. Sugarbaker PH. Surgical responsibilities in the management of peritoneal carcinomatosis. J Surg Oncol. 2010;101(8):713–24. doi: 10.1002/jso.21484.
    1. Glehen O, Osinsky D, Cotte E, Kwiatkowski F, Freyer G, Isaac S, et al. Intraperitoneal chemohyperthermia using a closed abdominal procedure and cytoreductive surgery for the treatment of peritoneal carcinomatosis: morbidity and mortality analysis of 216 consecutive procedures. Ann Surg Oncol. 2003;10(8):863–9. doi: 10.1245/ASO.2003.01.018.
    1. Elias D, Bonnay M, Puizillou JM, Antoun S, Demirdjian S, El OA, et al. Heated intra-operative intraperitoneal oxaliplatin after complete resection of peritoneal carcinomatosis: pharmacokinetics and tissue distribution. Ann Oncol. 2002;13(2):267–72. doi: 10.1093/annonc/mdf019.
    1. El-Kareh AW, Secomb TW. A theoretical model for intraperitoneal delivery of cisplatin and the effect of hyperthermia on drug penetration distance. Neoplasia. 2004;6(2):117–27. doi: 10.1593/neo.03205.
    1. Huang CQ, Feng JP, Yang XJ, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from colorectal cancer: a case-control study from a Chinese center. J Surg Oncol. 2014;109(7):730–9. doi: 10.1002/jso.23545.
    1. Coccolini F, Campanati L, Catena F, Ceni V, Ceresoli M, Jimenez CJ, et al. Hyperthermic intraperitoneal chemotherapy with cisplatin and paclitaxel in advanced ovarian cancer: a multicenter prospective observational study. J Gynecol Oncol. 2015;26(1):54–61. doi: 10.3802/jgo.2015.26.1.54.
    1. Li Y, Zhou YF, Liang H, Wang HQ, Hao JH, Zhu ZG, et al. Chinese expert consensus on the cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal malignancies. World J Gastroenterol. 2016;22(30):6906–16. doi: 10.3748/wjg.v22.i30.6906.
    1. Galanski M, Jakupec MA, Keppler BK. Update of the preclinical situation of anticancer platinum complexes: novel design strategies and innovative analytical approaches. Curr Med Chem. 2005;12(18):2075–94. doi: 10.2174/0929867054637626.
    1. Wheate NJ, Walker S, Craig GE, Oun R. The status of platinum anticancer drugs in the clinic and in clinical trials. Dalton Trans. 2010;39(35):8113–27. doi: 10.1039/c0dt00292e.
    1. Ali I, Wani WA, Saleem K, Haque A. Platinum compounds: a hope for future cancer chemotherapy. Anticancer Agents Med Chem. 2013;13(2):296–306. doi: 10.2174/1871520611313020016.
    1. Peng Y, Liu YE, Ren XC, Chen XJ, Su HL, Zong J, et al. A phase I clinical trial of dose escalation of lobaplatin in combination with fixed-dose docetaxel for the treatment of human solid tumours that had progressed following chemotherapy. Oncol Lett. 2015;9(1):67–74.
    1. Long GX, Lin JW, Liu DB, Zhou XY, Yuan XL, Hu GY, et al. Single-arm, multi-centre phase II study of lobaplatin combined with docetaxel for recurrent and metastatic nasopharyngeal carcinoma patients. Oral Oncol. 2014;50(8):717–20. doi: 10.1016/j.oraloncology.2014.04.007.
    1. Xie CY, Xu YP, Jin W, Lou LG. Antitumor activity of lobaplatin alone or in combination with antitubulin agents in non-small-cell lung cancer. Anticancer Drugs. 2012;23(7):698–705. doi: 10.1097/CAD.0b013e328352cc10.
    1. Yang XJ, Huang CQ, Suo T, Mei LJ, Yang GL, Cheng FL, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial. Ann Surg Oncol. 2011;18(6):1575–81. doi: 10.1245/s10434-011-1631-5.
    1. Sugarbaker PH. Successful management of microscopic residual disease in large bowel cancer. Cancer Chemother Pharmacol. 1999;43:15–25. doi: 10.1007/s002800051093.
    1. Sugarbaker PH. Cytoreductive surgery and peri-operative intraperitoneal chemotherapy as a curative approach to pseudomyxoma peritonei syndrome. Eur J Surg Oncol. 2001;27(3):239–43. doi: 10.1053/ejso.2000.1038.
    1. Elias D, Gilly F, Boutitie F, Quenet F, Bereder JM, Mansvelt B, et al. Peritoneal colorectal carcinomatosis treated with surgery and perioperative intraperitoneal chemotherapy: retrospective analysis of 523 patients from a multicentric French study. J Clin Oncol. 2010;28(1):63–8. doi: 10.1200/JCO.2009.23.9285.
    1. Liu Y, Yang T, Huang CQ, Li G, Li Y. Intraperitoneal chemotherapy for peritoneal carcinomatosis improves efficacy with acceptable safety: results of 200 cycles for 41 patients. Hepatogastroenterology. 2014;61(130):373–8.
    1. National Cancer Institute: Common Terminology Criteria for Adverse Events version 4.0. Available: . Accessed 11 Jan 2014.
    1. Verwaal VJ, Ruth SV, Bree ED, Sloothen GWV, Tinteren HV, Boot H, et al. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003;21(20):3737–43. doi: 10.1200/JCO.2003.04.187.
    1. Tang L, Mei LJ, Yang XJ, Huang CQ, Zhou YF, Yonemura Y, et al. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival of gastric cancer with peritoneal carcinomatosis: evidence from an experimental study. J Transl Med. 2011;9:53. doi: 10.1186/1479-5876-9-53.
    1. Spiliotis J, Halkia E, Lianos E, Kalantzi N, Grivas A, Efstathiou E, et al. Cytoreductive surgery and HIPEC in recurrent epithelial ovarian cancer: a prospective randomized phase III study. Ann Surg Oncol. 2015;22(5):1570–5. doi: 10.1245/s10434-014-4157-9.
    1. McKeage MJ. Lobaplatin: a new antitumour platinum drug. Expert Opin Investig Drugs. 2001;10(1):119–28. doi: 10.1517/13543784.10.1.119.
    1. Li X, Li Y. Clinical study on chemotherapy of lobaplatin combined with docetaxel in patients with relapsed ovarian cancer. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2014;39(11):1131–6.
    1. Li C, Zhang Y, Zhou J, Zhao G, Tang S. Therapeutic effect and tolerability of gelatin sponge particle-mediated chemoembolization for colorectal liver metastases: a retrospective study. World J Surg Oncol. 2013;11:222. doi: 10.1186/1477-7819-11-222.
    1. Ford H, Gounaris I. Docetaxel and its potential in the treatment of refractory esophagogastric adenocarcinoma. Therap Adv Gastroenterol. 2015;8(4):189–205. doi: 10.1177/1756283X15585468.
    1. Tan Q, Joshua AM, Saggar JK, Yu M, Wang M, Kanga N, et al. Effect of pantoprazole to enhance activity of docetaxel against human tumour xenografts by inhibiting autophagy. Br J Cancer. 2015;112(5):832–40. doi: 10.1038/bjc.2015.17.
    1. Chua TC, Saxena A, Schellekens JF, Liauw W, Yan TD, Fransi S, et al. Morbidity and mortality outcomes of cytoreductive surgery and perioperative intraperitoneal chemotherapy at a single tertiary institution: towards a new perspective of this treatment. Ann Surg. 2010;251(1):101–6. doi: 10.1097/SLA.0b013e3181b5ae43.
    1. Zhang YH, Li Y, Chen C, Peng CW. Carcinoembryonic antigen level is related to tumor invasion into the serosa of the stomach: study on 166 cases and suggestion for new therapy. Hepatogastroenterol. 2009;56(96):1750–4.
    1. Nakata B, Hirakawa YSCK, Kato Y, Yamashita Y, Maeda K, Onoda N, et al. Serum CA 125 level as a predictor of peritoneal dissemination in patients with gastric carcinoma. Cancer. 1998;83(12):2488–92. doi: 10.1002/(SICI)1097-0142(19981215)83:12<2488::AID-CNCR12>;2-1.
    1. Polat E, Duman U, Duman M, Derya Peker K, Akyuz C, Fatih Yasar N, et al. Preoperative serum tumor marker levels in gastric cancer. Pak J Med Sci. 2014;30(1):145–9.
    1. Huang XE, Wei GL, Huo JG, Wang XN, Lu YY, Wu XY, et al. Intrapleural or intraperitoneal lobaplatin for treatment of patients with malignant pleural effusion or ascites. Asian Pac J Cancer Prev. 2013;14(4):2611–4. doi: 10.7314/APJCP.2013.14.4.2611.

Source: PubMed

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