Sridhar K S, Hussein A M, Benedetto P, Waldman S M, Feun L G, Savaraj N, Richman S P, Ardalan B, Desai P
Department of Oncology, Sylvester Comprehensive Cancer Center, University of Miami School of Medicine, Jackson Memorial Hospital, Florida.
Am J Clin Oncol. 1991 Aug;14(4):298-304. doi: 10.1097/00000421-199108000-00005.
Nineteen patients with measurable and incurable head and neck carcinoma (17 squamous cell and two adenoid cystic) received intravenous bolus doses of 14 mg/m2 mitoxantrone in the first course. The doses were escalated or de-escalated by 2 mg/m2 in subsequent courses, based on leukocyte nadir, to achieve mild (3,000-3,999/mm3) or moderate (2,000-2,999/mm3) toxicity and response. The courses were repeated every 3 weeks. All 60 courses were evaluated for toxicity. Leukopenia was mild, moderate, severe (1,000-1,999/mm3), and life-threatening (less than 1,000/mm3) in 17%, 23%, 42%, and 2% of courses, respectively. Mild thrombocytopenia (100,000-129,999/mm3) occurred in two courses. The median interval to nadir leukopenia was 14 days (range 7-36) with a median of 13 days (range 3-50) to recover to normal. After the first course, leukopenia was mild in 16%, moderate in 32%, severe in 26%, and life-threatening in 5%. One patient died of pulmonary embolism 8 days after the first course and had concomitant leukocyte count of 700/mm3. Eighteen patients had at least one course resulting in leukopenia. Three of six patients receiving greater than or equal to 4 courses (cumulative dose 56-102 mg/m2) had an asymptomatic decrement of 14%, 17%, and 29%, respectively, in radionuclide left ventricular ejection fraction. The other toxicities were mild. In the 16 patients with squamous cell carcinoma that could be evaluated for response, one had a partial response lasting 8 months, and six had stable disease. One of the two patients with parotid adenoid cystic carcinoma had a minor response lasting 16 months. Mitoxantrone on a bolus schedule has minimal activity and is not indicated in head and neck squamous cell carcinoma.
19例患有可测量且无法治愈的头颈癌患者（17例鳞状细胞癌和2例腺样囊性癌）在首个疗程接受了静脉推注剂量为14mg/m²的米托蒽醌。在随后的疗程中，根据白细胞最低点，剂量以2mg/m²的幅度递增或递减，以达到轻度（3000 - 3999/mm³）或中度（2000 - 2999/mm³）毒性及反应。疗程每3周重复一次。对所有60个疗程进行了毒性评估。白细胞减少在各疗程中分别有17%为轻度、23%为中度、42%为重度（1000 - 1999/mm³）、2%为危及生命（低于1000/mm³）。轻度血小板减少（100000 - 129999/mm³）出现在两个疗程中。白细胞最低点的中位间隔时间为14天（范围7 - 36天），恢复正常的中位时间为13天（范围3 - 50天）。首个疗程后，白细胞减少情况为16%为轻度、32%为中度、26%为重度、5%为危及生命。1例患者在首个疗程后8天死于肺栓塞，当时白细胞计数为700/mm³。18例患者至少有一个疗程出现白细胞减少。在接受大于或等于4个疗程（累积剂量56 - 102mg/m²）的6例患者中，有3例放射性核素左心室射血分数分别无症状性下降了14%、17%和29%。其他毒性反应均较轻。在可评估反应的16例鳞状细胞癌患者中，1例出现部分缓解，持续8个月，6例病情稳定。2例腮腺腺样囊性癌患者中有1例出现轻微反应，持续16个月。推注方案的米托蒽醌活性极小，不用于头颈鳞状细胞癌。
