Abstract
Twenty-one chemotherapy-naive patients with unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) received a combination chemotherapy including cisplatin (CDDP), methotrexate (MTX), folinic acid (LFA) and 5-fluorouracil (5-FU). The doses of the 3 cytotoxic drugs were escalated until dose-limiting toxicity occurred in more than 1/3 of the patients. The treatment was generally well tolerated; no toxic deaths occurred. Only 2 patients showed dose-limiting neutropenia. Non-haematologic drug toxicities were infrequent and never reached grade 3. 3/21 (14%) complete responses and 6/21 (29%) partial responses were observed, for an overall response rate of 43%. 5/6 patients treated at step 5 achieved an objective response to treatment and 2 complete responses were observed in this group of patients. Although maximum tolerated doses (MTD) were not reached even at step 5, we decided to stop the escalation and to recommend this level for the phase II study. Our regimen combines a good tolerability with a high level of activity at step 5; a phase II study is currently ongoing.
| Original language | English |
|---|---|
| Pages (from-to) | 1207-1211 |
| Number of pages | 5 |
| Journal | Oncology Reports |
| Volume | 4 |
| Issue number | 6 |
| Publication status | Published - Nov 1997 |
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Keywords
- 5-fluorouracil
- Cisplatin
- Folinic acid
- Head and neck cancer
- Methotrexate
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
A phase I study of cisplatin, methotrexate, levofolinic acid and 5- fluorouracil in advanced squamous cell carcinoma of the head and neck. / Caponigro, Francesco; Comella, Pasquale; Daponte, Antonio; Gravina, Adriano; Carteni, Giacomo; Biglietto, Maria; Casaretti, Rossana; Frasci, Giuseppe; Ionna, Franco; Mozzillo, Nicola; Comella, Giuseppe.
In: Oncology Reports, Vol. 4, No. 6, 11.1997, p. 1207-1211.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A phase I study of cisplatin, methotrexate, levofolinic acid and 5- fluorouracil in advanced squamous cell carcinoma of the head and neck
AU - Caponigro, Francesco
AU - Comella, Pasquale
AU - Daponte, Antonio
AU - Gravina, Adriano
AU - Carteni, Giacomo
AU - Biglietto, Maria
AU - Casaretti, Rossana
AU - Frasci, Giuseppe
AU - Ionna, Franco
AU - Mozzillo, Nicola
AU - Comella, Giuseppe
PY - 1997/11
Y1 - 1997/11
N2 - Twenty-one chemotherapy-naive patients with unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) received a combination chemotherapy including cisplatin (CDDP), methotrexate (MTX), folinic acid (LFA) and 5-fluorouracil (5-FU). The doses of the 3 cytotoxic drugs were escalated until dose-limiting toxicity occurred in more than 1/3 of the patients. The treatment was generally well tolerated; no toxic deaths occurred. Only 2 patients showed dose-limiting neutropenia. Non-haematologic drug toxicities were infrequent and never reached grade 3. 3/21 (14%) complete responses and 6/21 (29%) partial responses were observed, for an overall response rate of 43%. 5/6 patients treated at step 5 achieved an objective response to treatment and 2 complete responses were observed in this group of patients. Although maximum tolerated doses (MTD) were not reached even at step 5, we decided to stop the escalation and to recommend this level for the phase II study. Our regimen combines a good tolerability with a high level of activity at step 5; a phase II study is currently ongoing.
AB - Twenty-one chemotherapy-naive patients with unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) received a combination chemotherapy including cisplatin (CDDP), methotrexate (MTX), folinic acid (LFA) and 5-fluorouracil (5-FU). The doses of the 3 cytotoxic drugs were escalated until dose-limiting toxicity occurred in more than 1/3 of the patients. The treatment was generally well tolerated; no toxic deaths occurred. Only 2 patients showed dose-limiting neutropenia. Non-haematologic drug toxicities were infrequent and never reached grade 3. 3/21 (14%) complete responses and 6/21 (29%) partial responses were observed, for an overall response rate of 43%. 5/6 patients treated at step 5 achieved an objective response to treatment and 2 complete responses were observed in this group of patients. Although maximum tolerated doses (MTD) were not reached even at step 5, we decided to stop the escalation and to recommend this level for the phase II study. Our regimen combines a good tolerability with a high level of activity at step 5; a phase II study is currently ongoing.
KW - 5-fluorouracil
KW - Cisplatin
KW - Folinic acid
KW - Head and neck cancer
KW - Methotrexate
UR - http://www.scopus.com/inward/record.url?scp=0030952567&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0030952567&partnerID=8YFLogxK
M3 - Article
C2 - 21590223
AN - SCOPUS:0030952567
VL - 4
SP - 1207
EP - 1211
JO - Oncology Reports
JF - Oncology Reports
SN - 1021-335X
IS - 6
ER -