Kimura T, Suzuki K, Motai H, Miyamoto N, Tsuge I, Ito Y, Baba S
Department of Otorhinolaryngology, Nagoya City University Medical School, Japan.
Acta Otolaryngol Suppl. 1996;525:135-41.
We conducted a randomized controlled study of streptococcal preparation OK-432 on 120 newly identified cases of laryngeal squamous cell carcinoma who were registered at 10 participating institutions between November 1984 and October 1989. The patients were divided into two groups: those in early stages (stage I or II) and those in advanced stages (stage III or IV); these groups were further subdivided into an immunotherapy group (receiving OK-432) and a control group (who did not receive OK-432). The usefulness of OK-432 was studied using the sealed envelope method. The basic therapy for all cases was radiotherapy and, when required, surgery. As adjuvant therapy, 5Fu or derivatives were administered to all cases from the beginning of the treatment period to one year after the basic therapy, with the exception of cases in whom side effects were serious enough to contraindicate use of the drug. The target administration period was 5 years. Of the initial 120 cases, 11 cases were disqualified (3 cases of double cancer and 8 of incomplete primary therapy) and the remaining 109 were used for evaluation. The 5-year survival rate and the 5-year recurrence-free rate were 76% and 84%, respectively, in the immunized groups (both the early and advanced groups), whereas the same rates for the control groups were 78% and 75%. There was a tendency for the immunized groups to enjoy a slightly longer recurrence-free period. Over a 24-month observation period the immunized group always had higher levels of peripheral leukocytes and peripheral lymphocytes; this difference was significant for the first 21 months. Inhibition of bone marrow function is sometimes observed with radiotherapy. It is hoped that, if this inhibition can be mitigated, it will be possible to assist the compromised immune system and maintain a certain level of immune performance which will prevent recurrence and improve survival rate. In the present study we observed a tendency of the lower recurrence rate in the immunized group, and we hypothesize that OK-432 is effective in extending the recurrence-free period.
我们对120例新确诊的喉鳞状细胞癌患者进行了链球菌制剂OK-432的随机对照研究。这些患者于1984年11月至1989年10月在10家参与研究的机构登记。患者分为两组：早期（I期或II期）患者和晚期（III期或IV期）患者；这些组又进一步细分为免疫治疗组（接受OK-432）和对照组（未接受OK-432）。使用密封信封法研究OK-432的有效性。所有病例的基本治疗方法是放疗，必要时进行手术。作为辅助治疗，除了副作用严重到禁忌使用该药物的病例外，所有病例从治疗期开始到基本治疗后一年都给予5Fu或其衍生物。目标给药期为5年。最初的120例病例中，11例被取消资格（3例双癌和8例原发性治疗不完全），其余109例用于评估。免疫组（早期和晚期组）的5年生存率和5年无复发生存率分别为76%和84%，而对照组的相同比率分别为78%和75%。免疫组有复发-free期略长的趋势。在24个月的观察期内，免疫组的外周血白细胞和外周血淋巴细胞水平始终较高；在最初的21个月里，这种差异具有统计学意义。放疗有时会观察到骨髓功能抑制。希望如果这种抑制能够减轻，就有可能辅助受损的免疫系统，维持一定水平的免疫功能，从而预防复发并提高生存率。在本研究中，我们观察到免疫组有较低复发率的趋势，我们推测OK-432在延长无复发期中有效。
