Asian Pacific Journal of Cancer Prevention

Asian Pacific Journal of Cancer Prevention (아시아태평양암예방학회)
권호 표지
DOI QR코드

DOI QR Code

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Wang, Tao (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Shi, Fan (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Yang, Yun-Yi (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Su, Jin (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Chai, Yan-Lan (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University) ;
  • Liu, Zi (Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University)
  • Published : 2015.09.02
Download PDF
⟨ Previous Next ⟩

Abstract

Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

Keywords

References

  1. Degardin M, Armand JP, Chevallier B, et al (1995). A clinical screening cooperative group phase II evaluation of lobaplatin (ASTA D-19466) in advanced head and neck cancer. Investigational New Drugs, 13, 253-5. https://doi.org/10.1007/BF00873809
  2. Deng QQ, Huang XE, Ye LH, et al (2013). Phase II trial of Loubo$^{(R)}$(Lobaplatin) and pemetrexed for patients with metastatic breast cancer not responding to anthracycline or taxanes. Asian Pac J Cancer Prev, 14, 413-7. https://doi.org/10.7314/APJCP.2013.14.1.413
  3. Eliopoulos AG, Kerr DJ, Maurer HR, Hilgard P, Spandidos DA (1995). Induction of the c-myc but not the cH-ras promoter by platinum compounds. Biochem Pharmacol, 50, 33-8. https://doi.org/10.1016/0006-2952(95)00085-E
  4. Engel JB, Martens T, Hahne JC, et al (2012). Effects of lobaplatin as a single agent and in combination with TRAIL on the growth of triple-negative p53-mutated breast cancers in vitro. Anti-Cancer Drugs, 23, 426-36. https://doi.org/10.1097/CAD.0b013e32834fb8ce
  5. Ferlay J, Soerjomataram I, Ervik M, et al (2013). GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide. In IARC CancerBase No. 11 (Internet). Lyon, France, International Agency for Research on Cancer. Available from, http://globocan.iarc.fr, accessed on day/month/year.
  6. Harstrick A, Bokemeyer C, Scharnofkse M, et al (1993). Preclinical activity of a new platinum analogue, lobaplatin, in cisplatin-sensitive and resistant human testicular, ovarian and gastric carcinoma cell lines. Cancer Chemother Pharmacol, 33, 43-7. https://doi.org/10.1007/BF00686021
  7. Huang XE, Wei GL, Huo JG, et al (2013). Intrapleural or intraperitoneal lobaplatin for treatment of patients with malignant pleural effusion or ascites. Asian Pac J Cancer Prev, 14, 2611-4. https://doi.org/10.7314/APJCP.2013.14.4.2611
  8. Hughes R (2008). NCI-CTC vs TNS, which tool is better for grading the severity of chemotherapy-induced peripheral neuropathy? Nature Clinical Practice Neurology, 4, 68-69.
  9. Li X, Ran L, Fang W, Wang D (2014). Lobaplatin arrests cell cycle progression, induces apoptosis and alters the proteome in human cervical cancer cell Line CaSki. Biomed Pharmacoth, 68, 291-7. https://doi.org/10.1016/j.biopha.2013.10.004
  10. McKeage M J (2001). Lobaplatin, a new antitumour platinum drug. Expert opinion on investigational drugs, 10, 119-28. https://doi.org/10.1517/13543784.10.1.119
  11. NCCN, Practice Guidelines in Oncology. 2013. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  12. Small W Jr, Mell LK, Anderson P, et al (2008). Consensus guidelines for delineation of clinical target volume for Intensity-Modulated pelvic radiotherapy in postoperative treatment of endometrial and cervical cancer. Int J Radiat Oncol Biol Phys, 71, 428-34. https://doi.org/10.1016/j.ijrobp.2007.09.042
  13. Tsuchida Y, Therasse P (2001). Response evaluation criteria in solid tumors (RECIST), new guidelines. Med Pediatr Oncol, 37,1-3. https://doi.org/10.1002/mpo.1154
  14. Wang N, Lv YZ, Xu AH, Huang YR, Peng L, Li JR (2014). Application of lobaplatin in trans-catheter arterial chemoembolization for primary hepatic carcinoma. Asian Pac J Cancer Prev, 15, 647-650. https://doi.org/10.7314/APJCP.2014.15.2.647
  15. Welink J, Boven E, Vermorken JB, Gall HE, van der Vijgh WJ (1999). Pharmacokinetics and pharmacodynamics of lobaplatin (D-19466) in patients with advanced solid tumors, including patients with impaired renal or liver function. Clin Cancer Res, 5, 2349-58.
  16. Whitney CW, Sause W, Bundy BN, et al (1999). Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in Stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes, a gynecologic oncology group and southwest oncology group study. J Clin Oncol, 17, 1339-48.
  17. Wiebe E, Denny L, Thomas G (2012). Cancer of the cervix uteri. Int J Gynaecol Obstet, 119, 100-9. https://doi.org/10.1016/S0020-7292(12)00434-1
  18. Xie CY, Xu YP, Jin W, Lou LG (2012). Antitumor activity of lobaplatin alone or in combination with antitubulin agents in non-small-cell lung cancer. Anticancer Drugs, 23, 698-705. https://doi.org/10.1097/CAD.0b013e328352cc10
  19. Zhao C, Wang XJ, Wang S, et al (2014). Lobaplatin Combined Floxuridine/Pirarubicin-based Transcatheter Hepatic Arterial Chemoembolization for Unresectable Primary Hepatocellular Carcinoma. Asian Pac J Cancer Prev, 15, 2057. https://doi.org/10.7314/APJCP.2014.15.5.2057

Cited by

  1. Anticancer function of α-solanine in lung adenocarcinoma cells by inducing microRNA-138 expression vol.37, pp.5, 2016, https://doi.org/10.1007/s13277-015-4528-2
  2. Folate-targeted perfluorohexane nanoparticles carrying bismuth sulfide for use in US/CT dual-mode imaging and synergistic high-intensity focused ultrasound ablation of cervical cancer vol.4, pp.23, 2016, https://doi.org/10.1039/C6TB00261G
  3. Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial vol.17, pp.1, 2017, https://doi.org/10.1186/s12885-017-3080-4
  4. A randomized and open-label phase II trial reports the efficacy of neoadjuvant lobaplatin in breast cancer vol.9, pp.1, 2018, https://doi.org/10.1038/s41467-018-03210-2
  5. Acute radiation toxicity during and after concurrent chemoradiotherapy in patients with localy advanced cervical cancer vol.10, pp.2, 2018, https://doi.org/10.5937/racter10-18049