Failure of the perioperative PCV neoadjuvant polychemotherapy in resectable bronchogenic non-small cell carcinoma. Results from a randomized phase II trial.
In 1985, the authors began a phase II study to assess the PCV perioperative polychemotherapy (cisplatin 100 mg/m2, cyclophosphamide 600 mg/m2, vindesine 3 mg/m2) in patients with resectable bronchogenic non-small cell carcinoma. Patients were randomized to receive either two preoperative courses of PCV chemotherapy, surgery, and two postoperative courses of PCV chemotherapy (PCV group) or immediate surgery (surgery group). A staging procedure using the CT scan was performed before randomization and, additionally, before surgery in the PCV group. There were 26 randomized patients, 13 in each group. In the PCV group, 11 patients agreed to receive the two preoperative courses of chemotherapy. A response was observed in five patients (45%), and a progression was observed in four patients (36%) leading to a cancellation of surgery in two of them. Postoperative care was the same for each group. Although no death could be related to chemotherapy, it was decided to stop entering new patients into this trial because of the rate of preoperative progression in the PCV group.
Dautzenberg
B
B
Service de Pneumologie et de Réanimation Respiratoire, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
Benichou
J
J
Allard
P
P
Lebeau
B
B
Coetmeur
D
D
Brechot
J M
JM
Postal
M J
MJ
Chastang
C
C
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002283:Carcinoma, Bronchogenic / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011897:Random Allocation; D015996:Survival Rate; D014751:Vindesine / Q000008:administration & dosage
D003520:Cyclophosphamide; D002945:Cisplatin; D014751:Vindesine