doxorubicin has clinical activity and can be delivered without major toxicity
to adults with advanced solid tumors affecting the lungs, according to a
multicenter phase I study reported at the 38th Annual Meeting of the American
Society of Clinical Oncology (abstract 1204).
Sunil Sharma, MD, of Memorial-Sloan Kettering Cancer Center,
reported the study involving 32 patients with solid tumors, primarily sarcoma,
non-small-cell lung cancer, bronchioloalveolor cancer, and mesothelioma.
Twenty-four patients had received chemotherapy, and 11 had received radiation
The patients received doxorubicin hydrochloride as a
sterile, pyrogen-free solution in two concentrations (16 mg/mL and 24 mg/mL) in
an ethanol/water vehicle using the OncoMyst delivery device. The agent,
Resmycin, was supplied by BattellePharma, Columbus, Ohio.
The treatment was given every 3 weeks for a maximum of six
treatments. The amount of aerosolized doxorubicin was determined by a Tc-99m
DTPA deposition test performed within 1 week prior to the first treatment.
According to Dr. Sharma, inhaled chemotherapy is optimal for
reaching the alveolar areas of the lung with minimal systemic absorption.
Doxorubicin is just one of various agents being studied for use with this
The treatment produced one partial response at a dose level
of 1.9 mg/m2
in a patient with spindle cell sarcoma. "Eight of the 32 patients demonstrated
stable disease at dose levels ranging from 1.5 to 3.8 mg/m2,"
Dr. Sharma reported.
The only observed dose-limiting toxicity was a 20% decline
in FVC (forced vital capacity) following the first course in one patient. Other
grade 1-2 toxicities included mainly cough, hypoxia during inhalation, loss of
appetite, and light-headedness. In some patients, cough and dyspnea were
already present; these symptoms worsened in some patients but improved in
others with treatment. No hematologic toxicities were observed.