A phase I/II trial of recombinant human granulocyte-macrophage colony-stimulating factor in the intensification of cisplatin and cyclophosphamide chemotherapy for advanced ovarian cancer.
A pilot study was undertaken in eight patients to assess the feasibility of recombinant human granulocyte-macrophage colony-stimulating factor (rH GM-CSF) support to intensify standard chemotherapy for advanced ovarian cancer using a shortened 15 day treatment interval. Only four patients completed the course of six cycles of cisplatin 75 mg m-2 and cyclophosphamide 750 mg m-2 with rH GM-CSF, 3-5 micrograms kg-1 day-1, days 3-14, but one of these suffered a toxic death on study. Another died of disease progression. There were two episodes of life-threatening infection (WHO grade 4), and three patients were withdrawn because of various rH GM-CSF-related problems. Although potentially affording some patients the hypothetical benefits of dose intensification, as well as the possible attraction of a shorter duration of chemotherapy, this regimen is not without problems.
Kehoe
S
S
Cancer Research Campaign Trials Unit, Queen Elizabeth Medical Centre, Birmingham, UK.
Poole
C J
CJ
Stanley
A
A
Earl
H M
HM
Blackledge
G R
GR
D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use* / Q000633:toxicity*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011994:Recombinant Proteins / Q000627:therapeutic use / Q000633:toxicity; D015996:Survival Rate
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; D002945:Cisplatin