Efficacy of gabapentin for the prevention of paclitaxel induced peripheral neuropathy: A randomized placebo controlled clinical trial

被引:37
作者
Aghili, Mahdi [1 ]
Zare, Mahkameh [2 ]
Mousavi, Nima [1 ]
Ghalehtaki, Reza [1 ]
Sotoudeh, Sarvazad [1 ]
Kalaghchi, Bita [3 ]
Akrami, Shahram [4 ]
Esmati, Ebrahim [3 ]
机构
[1] Univ Tehran Med Sci, Canc Inst, RORC, Tehran, Iran
[2] Iran Univ Med Sci, Hafte e Tir Hosp, Dept Radiat Oncol, Tehran, Iran
[3] Univ Tehran Med Sci, RORC, Canc Inst, Dept Radiat Oncol, Tehran, Iran
[4] Univ Tehran Med Sci, Dept Phys Med & Rehabil, Tehran, Iran
关键词
breast cancer; chemotherapy induced neuropathy; paclitaxel; CANCER INCIDENCE; DRUG-THERAPY; CHEMOTHERAPY; MANAGEMENT; PAIN; SUBUNIT; OXALIPLATIN; ALLODYNIA; NEURONTIN;
D O I
10.1111/tbj.13196
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Neuropathy is a dose limiting side effect of taxanes which may impact the quality of life and treatment outcomes. This randomized placebo-controlled double-blinded clinical trial was carried out to assess the efficacy of gabapentin in preventing chemotherapy induced neuropathy. Women with breast cancer were randomized into two groups of paclitaxel chemotherapy with gabapentin 300 mg/three times a day orally or placebo for 2 weeks started at day 1 of each paclitaxel cycle. Two groups were compared based on the relative frequency of neuropathy and change in nerve conducting velocity (NCV). Twenty women were assigned to each study arm. The majority of the neuropathy in gabapentin group was grade 1 in all of the four cycles with no event of >= grade 3 neuropathy in this group. Compared to the placebo, the rate of 2nd and 3rd grade neuropathy was significantly lower in the gabapentin group (P = 0.000). The change in NCV after four cycles of paclitaxel was significantly lower in the gabapentin group compared to the placebo group (17.7% vs 61.0% decline in NCV for sural and 21.9% vs 62.5% declines in NCV for peroneal nerve). Gabapentin given with paclitaxel is effective in the prevention of intermediate and high grade neuropathies both objectively and subjectively.
引用
收藏
页码:226 / 231
页数:6
相关论文
共 25 条
[1]   Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100 000 women in 123 randomised trials [J].
Albain, K. ;
Anderson, S. ;
Arriagada, R. ;
Barlow, W. ;
Bergh, J. ;
Bliss, J. ;
Buyse, M. ;
Cameron, D. ;
Carrasco, E. ;
Clarke, M. ;
Correa, C. ;
Coates, A. ;
Collins, R. ;
Costantino, J. ;
Cutter, D. ;
Cuzick, J. ;
Darby, S. ;
Davidson, N. ;
Davies, C. ;
Davies, K. ;
Delmestri, A. ;
Di Leo, A. ;
Dowsett, M. ;
Elphinstone, P. ;
Evans, V. ;
Ewertz, M. ;
Gelber, R. ;
Gettins, L. ;
Geyer, C. ;
Goldhirsch, A. ;
Godwin, J. ;
Gray, R. ;
Gregory, C. ;
Hayes, D. ;
Hill, C. ;
Ingle, J. ;
Jakesz, R. ;
James, S. ;
Kaufmann, M. ;
Kerr, A. ;
MacKinnon, E. ;
McGale, P. ;
McHugh, T. ;
Norton, L. ;
Ohashi, Y. ;
Paik, S. ;
Pan, H. C. ;
Perez, E. ;
Peto, R. ;
Piccart, M. .
LANCET, 2012, 379 (9814) :432-444
[2]   Cancer Incidence in Five Continents: Inclusion criteria, highlights from Volume X and the global status of cancer registration [J].
Bray, F. ;
Ferlay, J. ;
Laversanne, M. ;
Brewster, D. H. ;
Mbalawa, C. Gombe ;
Kohler, B. ;
Pineros, M. ;
Steliarova-Foucher, E. ;
Swaminathan, R. ;
Antoni, S. ;
Soerjomataram, I. ;
Forman, D. .
INTERNATIONAL JOURNAL OF CANCER, 2015, 137 (09) :2060-2071
[3]   Chemotherapy-induced peripheral neuropathy: Current status and progress [J].
Brewer, Jamie R. ;
Morrison, Gladys ;
Dolan, M. Eileen ;
Fleming, Gini F. .
GYNECOLOGIC ONCOLOGY, 2016, 140 (01) :176-183
[4]   Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015 [J].
Coates, A. S. ;
Winer, E. P. ;
Goldhirsch, A. ;
Gelber, R. D. ;
Gnant, M. ;
Piccart-Gebhart, M. ;
Thuerlimann, B. ;
Senn, H. -J. .
ANNALS OF ONCOLOGY, 2015, 26 (08) :1533-1546
[5]  
Crates, COMM TERM CRIT ADV E
[6]   International Variation in Female Breast Cancer Incidence and Mortality Rates [J].
DeSantis, Carol E. ;
Bray, Freddie ;
Ferlay, Jacques ;
Lortet-Tieulent, Joannie ;
Anderson, Benjamin O. ;
Jemal, Ahmedin .
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION, 2015, 24 (10) :1495-1506
[7]   Identification of the α2-δ-1 subunit of voltage-dependent calcium channels as a molecular target for pain mediating the analgesic actions of pregabalin [J].
Field, Mark J. ;
Cox, Peter J. ;
Stott, Emma ;
Melrose, Heather ;
Offord, James ;
Su, Ti-Zhi ;
Bramwell, Steve ;
Corradini, Laura ;
England, Steven ;
Winks, Joanna ;
Kinloch, Ross A. ;
Hendrich, Jan ;
Dolphin, Annette C. ;
Webb, Tony ;
Williams, Dic .
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2006, 103 (46) :17537-17542
[8]   Gabapentin (neurontin) and S-(+)-3-isobutylgaba represent a novel class of selective antihyperalgesic agents [J].
Field, MJ ;
Oles, RJ ;
Lewis, AS ;
McCleary, S ;
Hughes, J ;
Singh, L .
BRITISH JOURNAL OF PHARMACOLOGY, 1997, 121 (08) :1513-1522
[9]   Mechanical Allodynia Induced by Paclitaxel, Oxaliplatin and Vincristine: Different Effectiveness of Gabapentin and Different Expression of Voltage-Dependent Calcium Channel α2δ-1 Subunit [J].
Gauchan, Punarn ;
Andoh, Tsugunobu ;
Ikeda, Kenichiro ;
Fujita, Masahide ;
Sasaki, Atsushi ;
Kato, Atsushi ;
Kuraishi, Yasushi .
BIOLOGICAL & PHARMACEUTICAL BULLETIN, 2009, 32 (04) :732-734
[10]   The novel anticonvulsant drug, gabapentin (Neurontin), binds to the alpha(2)delta subunit of a calcium channel [J].
Gee, NS ;
Brown, JP ;
Dissanayake, VUK ;
Offord, J ;
Thurlow, R ;
Woodruff, GN .
JOURNAL OF BIOLOGICAL CHEMISTRY, 1996, 271 (10) :5768-5776