Abstract
Previous results from our preclinical studies have shown that lonidamine (LND) can positively modulate the antiproliferative activity of doxorubicin (DOX) on breast cancer cell lines. To evaluate the effect of LND in a clinical setting, a multicenter randomized trial was carried out on patients with advanced breast cancer. From September 1991 to July 1993, 181 patients were enrolled in the trial and received an initial treatment of DOX at 75 mg/m2 for 3 cycles. The 137 patients who reached complete remission, partial remission, or stable disease were randomized to receive either DOX alone (75 mg/m2 day 1) (arm A) or DOX plus LND (600 mg orally/day) (arm B). The patients enrolled in the two arms were fairly homogeneous in terms of major clinical characteristics. Toxicity was similar in both arms except for myalgia: WHO grade ≤ 2 was observed in 57% of arm B patients. Overall response rate to DOX+LND was 50% and to DOX alone 38% in evaluable patients, and 48% vs 37% in all registered patients, as determined by an intention-to-treat analysis. The differences did not reach statistical significance. Conversely, in agreement with previous findings, we observed a significant difference in response rate in the subgroup of patients with liver metastases, regardless of the extent of hepatic involvement (DOX+LND 68% vs DOX 33%, p = 0.03). This observation makes LND an important tool in association with anthracyclines in the treatment of this subgroup of patients.
| Original language | English |
|---|---|
| Pages (from-to) | 209-217 |
| Number of pages | 9 |
| Journal | Breast Cancer Research and Treatment |
| Volume | 49 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 1998 |
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Keywords
- Advanced breast cancer
- Doxorubicin
- Lonidamine
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Modulating effect of lonidamine on response to doxorubicin in metastatic breast cancer patients : Results front a multicenter prospective randomized trial. / Amadori, Dino; Frassineti, Giovanni Luca; De Matteis, Andrea; Mustacchi, Giorgio; Santoro, Antonio; Cariello, Salvatore; Ferrari, Massimo; Nascimben, Ottorino; Nanni, Oriana; Lombardi, Alessandra; Scarpi, Emanuela; Zoli, Wainer.
In: Breast Cancer Research and Treatment, Vol. 49, No. 3, 1998, p. 209-217.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Modulating effect of lonidamine on response to doxorubicin in metastatic breast cancer patients
T2 - Results front a multicenter prospective randomized trial
AU - Amadori, Dino
AU - Frassineti, Giovanni Luca
AU - De Matteis, Andrea
AU - Mustacchi, Giorgio
AU - Santoro, Antonio
AU - Cariello, Salvatore
AU - Ferrari, Massimo
AU - Nascimben, Ottorino
AU - Nanni, Oriana
AU - Lombardi, Alessandra
AU - Scarpi, Emanuela
AU - Zoli, Wainer
PY - 1998
Y1 - 1998
N2 - Previous results from our preclinical studies have shown that lonidamine (LND) can positively modulate the antiproliferative activity of doxorubicin (DOX) on breast cancer cell lines. To evaluate the effect of LND in a clinical setting, a multicenter randomized trial was carried out on patients with advanced breast cancer. From September 1991 to July 1993, 181 patients were enrolled in the trial and received an initial treatment of DOX at 75 mg/m2 for 3 cycles. The 137 patients who reached complete remission, partial remission, or stable disease were randomized to receive either DOX alone (75 mg/m2 day 1) (arm A) or DOX plus LND (600 mg orally/day) (arm B). The patients enrolled in the two arms were fairly homogeneous in terms of major clinical characteristics. Toxicity was similar in both arms except for myalgia: WHO grade ≤ 2 was observed in 57% of arm B patients. Overall response rate to DOX+LND was 50% and to DOX alone 38% in evaluable patients, and 48% vs 37% in all registered patients, as determined by an intention-to-treat analysis. The differences did not reach statistical significance. Conversely, in agreement with previous findings, we observed a significant difference in response rate in the subgroup of patients with liver metastases, regardless of the extent of hepatic involvement (DOX+LND 68% vs DOX 33%, p = 0.03). This observation makes LND an important tool in association with anthracyclines in the treatment of this subgroup of patients.
AB - Previous results from our preclinical studies have shown that lonidamine (LND) can positively modulate the antiproliferative activity of doxorubicin (DOX) on breast cancer cell lines. To evaluate the effect of LND in a clinical setting, a multicenter randomized trial was carried out on patients with advanced breast cancer. From September 1991 to July 1993, 181 patients were enrolled in the trial and received an initial treatment of DOX at 75 mg/m2 for 3 cycles. The 137 patients who reached complete remission, partial remission, or stable disease were randomized to receive either DOX alone (75 mg/m2 day 1) (arm A) or DOX plus LND (600 mg orally/day) (arm B). The patients enrolled in the two arms were fairly homogeneous in terms of major clinical characteristics. Toxicity was similar in both arms except for myalgia: WHO grade ≤ 2 was observed in 57% of arm B patients. Overall response rate to DOX+LND was 50% and to DOX alone 38% in evaluable patients, and 48% vs 37% in all registered patients, as determined by an intention-to-treat analysis. The differences did not reach statistical significance. Conversely, in agreement with previous findings, we observed a significant difference in response rate in the subgroup of patients with liver metastases, regardless of the extent of hepatic involvement (DOX+LND 68% vs DOX 33%, p = 0.03). This observation makes LND an important tool in association with anthracyclines in the treatment of this subgroup of patients.
KW - Advanced breast cancer
KW - Doxorubicin
KW - Lonidamine
UR - http://www.scopus.com/inward/record.url?scp=7344255198&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=7344255198&partnerID=8YFLogxK
U2 - 10.1023/A:1006063412726
DO - 10.1023/A:1006063412726
M3 - Article
C2 - 9776504
AN - SCOPUS:7344255198
VL - 49
SP - 209
EP - 217
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 3
ER -