Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas

Abstract

Standardized guidelines for response assessment are needed to ensure comparability among clinical trials in non-Hodgkin's lymphomas (NHL). To achieve this, two meetings were convened among United States and international lymphoma experts representing medical hematology/oncology, radiology, radiation oncology, and pathology to review currently used response definitions and to develop a uniform set of criteria for assessing response in clinical trials. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. Single-photon emission computed tomography gallium scans are encouraged as a valuable adjunct to assessment of patients with large-cell NHL, but such scans require appropriate expertise. Flow cytometric, cytogenetic, and molecular studies are not currently included in response definitions. Response rates may be the most important objective in phase II trials where the activity of a new agent is important and may provide support for approval by regulatory agencies. However, the goals of most phase III trials are to identify therapies that will prolong the progression-free survival, if not the overall survival, of the treated patients. We hope that these guidelines will serve to improve communication among investigators and comparability among clinical trials until clinically relevant laboratory and imaging studies are identified and become more widely available.

Romidepsin induces durable responses in patients with relapsed or refractory angioimmunoblastic T‐cell lymphoma

“…Response was assessed every two cycles by both investigators and an independent review committee (IRC; expert radiologists and hematologic oncologists) according to the 1999 IWG guidelines for NHL (IWG‐NHL) 14. All descriptive statistical analyses were performed by using SAS statistical software version 9.2 (SAS Institute, Cary, NC, USA).…”

Gemcitabine, cisplatin and methylprednisolone (GEM-P) is an effective salvage regimen in patients with relapsed and refractory lymphoma

“…The RECIST criteria were chosen because of the heterogeneity of the patient population, which included both patients with HL and NHL, as well as those with visceral disease. In these patients, neither the Cotswold criteria (Lister et al, 1989) nor the International Workshop NHL response criteria (Cheson et al, 1999) could be strictly applied.…”

Prospective subgroup analyses of the randomized MCL‐002 (SPRINT) study: lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma

“…Final variables were selected using a stepwise selection method with entry level P  =   0·20 and stay level P  =   0·15. ORR was defined according to Cheson et al (1999) and statistical significance determined by Wald Χ 2 test ( P  <   0·05).…”