PMID- 9554537
OWN - NLM
STAT- MEDLINE
DCOM- 19980429
LR  - 20131121
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 82
IP  - 8
DP  - 1998 Apr 15
TI  - Dihydro-5-azacytidine and cisplatin in the treatment of malignant mesothelioma: a 
      phase II study by the Cancer and Leukemia Group B.
PG  - 1578-84
AB  - BACKGROUND: In a prior Cancer and Leukemia Group B (CALGB) Phase II trial of 
      patients with advanced, previously untreated mesothelioma, dihydro-5-azacytidine 
      (DHAC) demonstrated a 17% response rate, including 1 complete response, with only 
      mild myelosuppression. This Phase II study (CALGB 9031) was conducted to 
      determine the effectiveness of and toxicities that would result from adding 
      cisplatin to DHAC administered to the same patient population. METHODS: 
      Thirty-six patients were treated with concurrent DHAC at 1500 mg/m2/day for 5 
      days by continuous infusion and cisplatin 15 mg/m2 daily for 5 days. Therapy was 
      repeated every 3 weeks. Cisplatin was to be increased to 20 mg/m2 daily in 
      subsequent cycles if toxicity was minimal. Therapy was continued until disease 
      progression or excessive toxicity mandated discontinuation. RESULTS: Overall, 5 
      objective responses were observed in 29 evaluated patients (objective response 
      rate, 17%). The median duration of response was 6.6 months. Median survival was 
      6.4 months, with a median time to clinical failure of 2.7 months. The major 
      toxicity noted was significant chest/pericardial pain, as was observed with DHAC 
      alone. There were 2 early deaths of unknown cause on Days 9 and 17 of therapy, 
      respectively. Significant leukopenia was observed in 29% of patients, but there 
      were no neutropenic fevers. CONCLUSIONS: The addition of cisplatin to DHAC did 
      not increase the response rate over that observed with DHAC alone in patients 
      with mesothelioma; however, it did increase toxicity, especially leukopenia. This 
      combination is not recommended for further studies involving mesothelioma 
      patients.
FAU - Samuels, B L
AU  - Samuels BL
AD  - Lutheran General Hospital, Park Ridge, Illinois 60068, USA.
FAU - Herndon, J E 2nd
AU  - Herndon JE 2nd
FAU - Harmon, D C
AU  - Harmon DC
FAU - Carey, R
AU  - Carey R
FAU - Aisner, J
AU  - Aisner J
FAU - Corson, J M
AU  - Corson JM
FAU - Suzuki, Y
AU  - Suzuki Y
FAU - Green, M R
AU  - Green MR
FAU - Vogelzang, N J
AU  - Vogelzang NJ
LA  - eng
GR  - CA 12449/CA/NCI NIH HHS/United States
GR  - CA 31946/CA/NCI NIH HHS/United States
GR  - CA 33601/CA/NCI NIH HHS/United States
GR  - etc.
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Antineoplastic Agents)
RN  - 0627D8VG1C (5,6-dihydro-5-azacytidine)
RN  - M801H13NRU (Azacitidine)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Azacitidine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Chest Pain/chemically induced
MH  - Cisplatin/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Leukopenia/chemically induced
MH  - Male
MH  - Mesothelioma/*drug therapy/mortality/pathology
MH  - Middle Aged
MH  - Pleural Neoplasms/*drug therapy/mortality/pathology
MH  - Prognosis
MH  - Survival Analysis
EDAT- 1998/04/29 06:33
MHDA- 2000/06/20 09:00
CRDT- 1998/04/29 06:33
PHST- 1998/04/29 06:33 [pubmed]
PHST- 2000/06/20 09:00 [medline]
PHST- 1998/04/29 06:33 [entrez]
AID - 10.1002/(SICI)1097-0142(19980415)82:8<1578::AID-CNCR21>3.0.CO;2-0 [pii]
PST - ppublish
SO  - Cancer. 1998 Apr 15;82(8):1578-84.