Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1905-1912 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 35 |
| Issue number | 17 |
| DOIs | |
| Publication status | Published - 2017 |
Fingerprint
Cite this
Final Results of the IELSG-19 Randomized Trial of Mucosa-Associated Lymphoid Tissue Lymphoma: Improved Event-Free and Progression-Free Survival With Rituximab Plus Chlorambucil Versus Either Chlorambucil or Rituximab Monotherapy. / Zucca, Emanuele; Conconi, Annarita; Martinelli, G; Bouabdallah, R; Tucci, Alessandra; Vitolo, Umberto; Martelli, M; Pettengell, R; Salles, Gilles; Sebban, C; Guillermo, AL; Pinotti, Graziella; Devizzi, L; Morschhauser, F; Tilly, H; Torri, V; Hohaus, S; Ferreri, AJM; Zachée, P; Bosly, A; Haioun, C; Stelitano, C; Bellei, M; Ponzoni, M; Moreau, A; Jack, A; Campo, E; Mazzucchelli, L; Cavalli, Franco; Johnson, P; Thieblemont, C.
In: Journal of Clinical Oncology, Vol. 35, No. 17, 2017, p. 1905-1912.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Final Results of the IELSG-19 Randomized Trial of Mucosa-Associated Lymphoid Tissue Lymphoma: Improved Event-Free and Progression-Free Survival With Rituximab Plus Chlorambucil Versus Either Chlorambucil or Rituximab Monotherapy
AU - Zucca, Emanuele
AU - Conconi, Annarita
AU - Martinelli, G
AU - Bouabdallah, R
AU - Tucci, Alessandra
AU - Vitolo, Umberto
AU - Martelli, M
AU - Pettengell, R
AU - Salles, Gilles
AU - Sebban, C
AU - Guillermo, AL
AU - Pinotti, Graziella
AU - Devizzi, L
AU - Morschhauser, F
AU - Tilly, H
AU - Torri, V
AU - Hohaus, S
AU - Ferreri, AJM
AU - Zachée, P
AU - Bosly, A
AU - Haioun, C
AU - Stelitano, C
AU - Bellei, M
AU - Ponzoni, M
AU - Moreau, A
AU - Jack, A
AU - Campo, E
AU - Mazzucchelli, L
AU - Cavalli, Franco
AU - Johnson, P
AU - Thieblemont, C
PY - 2017
Y1 - 2017
N2 - There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m2/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m2 intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.
AB - There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m2/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m2 intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.
U2 - 10.1200/JCO.2016.70.6994
DO - 10.1200/JCO.2016.70.6994
M3 - Article
VL - 35
SP - 1905
EP - 1912
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 17
ER -