Phase II trial of mitoxantrone in head and neck carcinoma

K. S. Sridhar, A. M. Hussein, Pasquale W Benedetto, S. M. Waldman, Lynn G Feun, Niramol Savaraj, Stephen P Richman, Bach Ardalan, P. Desai

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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 (<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 ≥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.

Original languageEnglish
Pages (from-to)298-304
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume14
Issue number4
StatePublished - Jan 1 1991

Fingerprint

Mitoxantrone
Neck
Head
Leukopenia
Carcinoma
Adenoids
Adenoid Cystic Carcinoma
Pulmonary Embolism
Leukocyte Count
Radioisotopes
Thrombocytopenia
Stroke Volume
Squamous Cell Carcinoma
Appointments and Schedules
Leukocytes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II trial of mitoxantrone in head and neck carcinoma. / Sridhar, K. S.; Hussein, A. M.; Benedetto, Pasquale W; Waldman, S. M.; Feun, Lynn G; Savaraj, Niramol; Richman, Stephen P; Ardalan, Bach; Desai, P.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 14, No. 4, 01.01.1991, p. 298-304.

Research output: Contribution to journalArticle

@article{484f932408a34625b6ad9cd3376b21d2,
title = "Phase II trial of mitoxantrone in head and neck carcinoma",
abstract = "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 (<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 ≥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.",
author = "Sridhar, {K. S.} and Hussein, {A. M.} and Benedetto, {Pasquale W} and Waldman, {S. M.} and Feun, {Lynn G} and Niramol Savaraj and Richman, {Stephen P} and Bach Ardalan and P. Desai",
year = "1991",
month = "1",
day = "1",
language = "English",
volume = "14",
pages = "298--304",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

TY - JOUR

T1 - Phase II trial of mitoxantrone in head and neck carcinoma

AU - Sridhar, K. S.

AU - Hussein, A. M.

AU - Benedetto, Pasquale W

AU - Waldman, S. M.

AU - Feun, Lynn G

AU - Savaraj, Niramol

AU - Richman, Stephen P

AU - Ardalan, Bach

AU - Desai, P.

PY - 1991/1/1

Y1 - 1991/1/1

N2 - 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 (<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 ≥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.

AB - 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 (<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 ≥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.

UR - http://www.scopus.com/inward/record.url?scp=0025824337&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025824337&partnerID=8YFLogxK

M3 - Article

C2 - 1650529

AN - SCOPUS:0025824337

VL - 14

SP - 298

EP - 304

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 4

ER -