title: Ten-year follow-up results of a randomised controlled study comparing level-I vs level-III axillary lymph node dissection for primary breast cancer.
abstract: The most appropriate level of axillary dissection for breast cancer remains unclear. The present randomised study compared the treatment results of level-I vs level-III dissection in T1/2/3 and N0/1a/1b (1987 UICC classification) breast cancer without distant metastasis. Between 1995 and 1997, 522 patients were enrolled, and 514 were eligible. They were stratified into breast-conserving surgery or mastectomy, and then further stratified into level-III dissection (group-A, n=258) or level-I dissection (group-B, n=256). All patients were given oral 5-fluorouracil at 200 mg day-1 and tamoxifen at 20 mg day-1, daily for 2 years. Group-A resulted in a significantly longer operation time (77.0 vs 60.5 min, P<0.0001) and significantly larger blood loss (62.1 vs 48.1 ml, P<0.0001) than group-B, but in no significant differences in the frequencies of arm oedema and shoulder disturbance. Group-A resulted in a significantly larger number of dissected nodes than group-B (18.7 vs 14.8, P<0.0001), but in no differences in the number of involved nodes (1.54 vs 1.44). There were no significant differences in the 10-year overall and disease-free survival rates: 89.6 and 76.6% for group-A vs 87.8 and 74.1% for group-B, respectively. In conclusion, level-III dissection resulted in a longer operation time and greater blood loss than level-I, but did not improve the survival rate. Level-III dissection is not a recommended surgery for T1-3/N0-1b breast cancer.
authors.affiliation: Kodama Breast Clinic, Kitano-kamihakubai-cho-35, Kita-ku, Kyoto, Japan. kodama-breast-clinic@theia.ocn.ne.jp
authors.forename: H
authors.initials: H
authors.lastname: Kodama
authors.forename: Y
authors.initials: Y
authors.lastname: Nio
authors.forename: C
authors.initials: C
authors.lastname: Iguchi
authors.forename: N
authors.initials: N
authors.lastname: Kan
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001365:Axilla / Q000601:surgery; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008198:Lymph Nodes / Q000601:surgery*; D008207:Lymphatic Metastasis / Q000473:pathology; D008408:Mastectomy / Q000379:methods; D015412:Mastectomy, Segmental / Q000379:methods; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D013629:Tamoxifen / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D013629:Tamoxifen; D005472:Fluorouracil