BACKGROUND: Whether the administration of calcium (Ca) and magnesium (Mg) can reduce oxaliplatin-related neurotoxicity remains controversial. In addition, little is known about the effects of Ca/Mg on the blood level of platinum or objective tumor progression. PATIENTS AND METHODS: Patients receivingmodified FOLFOX6for metastatic colorectal cancer were double-blinded and randomized to receive additional treatment with Ca/Mg or placebo before and after the administration of oxaliplatin. The plasma and ultrafiltrable concentrations of platinum during the first and fifth cycles of treatment were determined using inductively coupled plasma spectrometry. RESULTS: Patients were randomized to receive Ca/Mg (Ca/Mg group, n = 17) or placebo (placebo group, n = 16) before and after the administration of oxaliplatin (85 mg/m(2)). The incidence of neurotoxicity after six cycles was not significantly different between the two groups. Blood concentrations of platinum at each time and the area under the curve were also not significantly different between the two groups. Furthermore, the response rate (RR) and disease control rate (DCR) did not differ significantly between the two groups (Ca/Mg group: RR 36%, DCR 73%. Placebo group: RR 40%, DCR 70%, P > 0.99). The median progression-free survival time was 9.2 months in the Ca/Mg group and 8.1 months in the control group; these survival times were not significantly different (P = 0.56). CONCLUSION: These data are insufficient to conclude with any certainty that the administration of Ca/Mg is not neuroprotective; however, the administration of Ca/Mg may not have any influence on antitumor activity and the blood concentration profile of platinum in patients receivingoxaliplatin-based chemotherapy.
RCT Entities:
BACKGROUND: Whether the administration of calcium (Ca) and magnesium (Mg) can reduce oxaliplatin-related neurotoxicity remains controversial. In addition, little is known about the effects of Ca/Mg on the blood level of platinum or objective tumor progression. PATIENTS AND METHODS: Patients receiving modified FOLFOX6 for metastatic colorectal cancer were double-blinded and randomized to receive additional treatment with Ca/Mg or placebo before and after the administration of oxaliplatin. The plasma and ultrafiltrable concentrations of platinum during the first and fifth cycles of treatment were determined using inductively coupled plasma spectrometry. RESULTS:Patients were randomized to receive Ca/Mg (Ca/Mg group, n = 17) or placebo (placebo group, n = 16) before and after the administration of oxaliplatin (85 mg/m(2)). The incidence of neurotoxicity after six cycles was not significantly different between the two groups. Blood concentrations of platinum at each time and the area under the curve were also not significantly different between the two groups. Furthermore, the response rate (RR) and disease control rate (DCR) did not differ significantly between the two groups (Ca/Mg group: RR 36%, DCR 73%. Placebo group: RR 40%, DCR 70%, P > 0.99). The median progression-free survival time was 9.2 months in the Ca/Mg group and 8.1 months in the control group; these survival times were not significantly different (P = 0.56). CONCLUSION: These data are insufficient to conclude with any certainty that the administration of Ca/Mg is not neuroprotective; however, the administration of Ca/Mg may not have any influence on antitumor activity and the blood concentration profile of platinum in patients receiving oxaliplatin-based chemotherapy.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: F Levi; B Perpoint; C Garufi; C Focan; P Chollet; P Depres-Brummer; R Zidani; S Brienza; M Itzhaki; S Iacobelli Journal: Eur J Cancer Date: 1993 Impact factor: 9.162
Authors: Alexandre Chan; Daniel L Hertz; Manuel Morales; Elizabeth J Adams; Sharon Gordon; Chia Jie Tan; Nathan P Staff; Jayesh Kamath; Jeong Oh; Shivani Shinde; Doreen Pon; Niharkia Dixit; James D'Olimpio; Cristina Dumitrescu; Margherita Gobbo; Kord Kober; Samantha Mayo; Linda Pang; Ishwaria Subbiah; Andreas S Beutler; Katherine B Peters; Charles Loprinzi; Maryam B Lustberg Journal: Support Care Cancer Date: 2019-07-30 Impact factor: 3.603
Authors: Charles L Loprinzi; Rui Qin; Shaker R Dakhil; Louis Fehrenbacher; Kathleen A Flynn; Pamela Atherton; Drew Seisler; Rubina Qamar; Grant C Lewis; Axel Grothey Journal: J Clin Oncol Date: 2013-12-02 Impact factor: 44.544
Authors: Jason A Sprowl; Giuliano Ciarimboli; Cynthia S Lancaster; Hugh Giovinazzo; Alice A Gibson; Guoqing Du; Laura J Janke; Guido Cavaletti; Anthony F Shields; Alex Sparreboom Journal: Proc Natl Acad Sci U S A Date: 2013-06-17 Impact factor: 11.205