Conditional survival (CS) of metastatic renal cell carcinoma (mRCC) patients treated with high dose interleukin-2 (HD IL-2).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 460-460
Author(s):  
Kinjal Parikh ◽  
David D. Stenehjem ◽  
Arun Sendilnathan ◽  
Hilda Crispin ◽  
Joan Van Atta ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Performance Status ◽  
Interleukin 2 ◽  
Risk Groups ◽  
High Dose ◽  
University Of Utah ◽  
Kaplan Meier ◽  
Prognostic Groups ◽  
The University ◽  
Survival Interval

460 Background: CS is a clinically useful prediction measure that adjusts prognosis of patients on the basis of survival since treatment initiation or therapy duration. CS was recently reported in mRCC patients treated with VEGF targeted therapy in patients stratified by Heng’s criteria. CS has not been reported in mRCC in the context of treatment with HD IL-2. Methods: Patients with histologically confirmed clear cell mRCC treated with HD IL-2 at the University of Utah Huntsman Cancer Institute from 2000 to 2012 were evaluated. Performance status and prognostic risk groups were included. Two-year CS was defined as the probability of surviving an additional 2 years from initiation of HD IL-2 to 18 months after the start of HD IL-2 at 3-month intervals estimated by Kaplan-Meier methodology. Results: A total of 85 patients were included with a median age of 56 years (range 32-76 years) and 79% (n = 67) were male. The median overall survival from HD IL-2 administration was 817 days. Stratification by Heng’s criteria at therapyinitiation resulted in survival estimates for the favorable (n = 13; 15%), intermediate (n = 56; 66%) and poor (n = 16; 19%) prognostic groups of 1616 (p = 0.1993 vs intermediate), 817 (p = 0.0041 vs poor), and 365 (p < 0.0001 vs favorable) days, respectively. Two-year overall CS increased from 56.2% at therapy initiation to 89.5% at 18 months (Table). Two-year CS stratified by Heng’s favorable, intermediate, and poor prognostic risk groups is presented in the Table. Conclusions: CS is a relevant prediction measure in the context of mRCC treated with HD IL-2.A longer survival interval from HD IL-2 treatment was associated with an increased survival probability. CS in this cohort was especially relevant in adjusting prognosis for patients with Heng’s intermediate risk. [Table: see text]

Pre-Treatment Serum Soluble Interleukin-2 Receptor Value Significantly Predicts Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3948-3948
Author(s):  
Shinsuke Noguchi ◽  
Masanobu Nakata ◽  
Kanako Shima ◽  
Yuki Katsura ◽  
Toshihiro Matsukawa ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Performance Status ◽  
Interleukin 2 ◽  
B Cell Lymphoma ◽  
Risk Groups ◽  
Newly Diagnosed ◽  
Extranodal Disease ◽  
Soluble Interleukin 2 Receptor ◽  
Pre Treatment ◽  
Significant Factors

Abstract Abstract 3948 Poster Board III-884 Serum soluble interleukin-2 receptor (sIL2R) is known to be elevated in patients with adult T-cell leukemia, non-Hodgkin lymphoma and Hodgkin lymphoma. Some studies reported the clinical usefulness of pre-treatment sIL2R value as a prognostic factor associated with survival in various NHL. However it has not been adequately examined about the significance of pre-treatment sIL2R value in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL), especially in rituximab era. We retrospectively analyzed the clinical significance of pre-treatment sIL2R value in 90 patients diagnosed as having DLBCL and treated in our hospital between 2004 and 2008. And we also compared them to patients with follicular lymphoma (FL) and to patinets with lymphadenopathy other than lymphoma. Median age of all 90 patients with DLBCL was 68 years (range, 18 to 88). Thirty-one (34%) patients were less than 60 years. Male/female was 53/37. Thirty-three (37%) patients had stage I or II diseases. Sixty-five (72%) patients were in 0/1 of ECOG performance status (PS). LDH value was elevated above normal range in 55 (61%) patients. Sixteen (18%) patients had 2 or more extranodal diseases. According to International Prognostic Index (IPI), 48 patients and 42 patients were classified as low/low-intermediate risk groups and high-intermediate/high risk groups, respectively. Seventy-nine of 90 patients were treated with R-CHOP or R-CHOP-like chemotherapies with or without radiotherapy. Two-year overall survival rate was 68% in all 90 patients with DLBCL. In all 90 patients with DLBCL, pre-treatment sIL2R value was 4258+/-6850 U/ml (mean+/-SD) which was significantly higher than that in 42 patients with lymphadenopathy other than lymphoma (870+/-892, p<0.0001, t-test). But it was not statistically different between patients with DLBCL and 56 patients with FL (2869+/-3642). In prognostic factor analysis in DLBCL, we examined 6 factors (age, stage, performance status, number of extranodal disease, LDH value and pre-treatment sIL2R value).Univariate analysis showed that stage, LDH, PS and sIL2R were statistically significant factors associated with survival, but age and number of extranodal disease were not. Thirty patients with lower sIL2R (less than 1000U/ml) showed better survival than 60 patients with higher sIL2R (1000U/ml or more). Two-year survival rates were 97% and 53%, respectively (p=0.0002, log-rank test). In these 4 significant factors, multivariate analysis showed sIL2R was the only statistically significant prognostic factor (HR 10.798, 95%CI: 1.320-88.304, p=0.0265). This retrospective analysis suggested that in rituximab era pre-treatment sIL2R value was a useful prognostic factor other than IPI in patients with newly diagnosed DLBCL. Disclosures: No relevant conflicts of interest to declare.

Associations between K-ras mutation, smoking, and prognosis of pancreatic cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 298-298
Author(s):  
Kei Saito ◽  
Yousuke Nakai ◽  
Hiroyuki Isayama ◽  
Takashi Sasaki ◽  
Naminatsu Takahara ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Colon Cancer ◽  
Cox Regression ◽  
Performance Status ◽  
Rank Test ◽  
Ras Mutation ◽  
Kaplan Meier ◽  
Never Smokers ◽  
Poor Outcomes ◽  
The University

298 Background: Smoking is recognized as a risk factor for pancreatic cancer, but its associations with prognosis are not fully elucidated. Smoking was associated with poor outcomes in colon cancer, especially in patients with K-ras mutation (J Clin Oncol. 2013;31:2016-23). Therefore, we conducted this retrospective analysis of the associations of K-ras mutation, smoking and prognosis in patients with pancreatic cancer. Methods: Patients with pancreatic cancer who received surgery or chemotherapy at the University of Tokyo Hospital were retrospectively studied. The prognosis of patients with mutant and wild K-ras were compared. Overall survival was evaluated using Kaplan-Meier methods and compared by long-rank test. Cox regression models were used to calculate hazard ratios (HRs) to evaluate the prognostic factors in patients with pancreatic cancer with mutant K-ras or wild K-ras. Results: Between January 2009 and August 2013, K-ras mutation analysis was evaluated in 187 patients (47 surgical resection and 140 chemotherapy). K-ras mutation was detected in 74.3%. The rates of current-, ex- and never-smokers were 18.2%, 31.6% and 50.3%, respectively. In patients with mutant K-ras, the rate of male gender (46.0% vs. 29.0%), presence of distant metastasis (50.4% vs. 31.3%) and median CA19-9 (374 U/mL vs. 136 U/mL) were significantly higher than that in patients with wild K-ras. The rate of ever smokers (current- and ex-smokers) did not differ significantly (48.2% in mutant K-ras vs. 56.3% in wild K-ras, p=0.403). Median survival time (MST) was 16.7 (95%CI, 11.9-21.8) months in patients with mutant K-ras, compared with 20.3 (95%CI, 15.8-34.6) in patients with wild K-ras (p=0.193). Meanwhile, MST was 22.2 (95%CI, 16.9-27.9) vs. 14.8 (95%CI, 9.1-19.4) months in patients with and without smoking (p=0.024). After adjustment by age, gender, performance status, CA19-9 and treatment, HRs of smoking were 1.96 (95%CI, 1.06-3.68, p=0.032) in patients with mutant K-ras, but the association was not significant in patients with wild-K-ras (HR 1.35 [95%CI, 0.37-5.28], p=0.653). Conclusions: As previously reported in colon cancer, smoking was associated with poor prognosis in pancreatic cancer with K-ras mutation.

Prognostication in non-small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18098-e18098
Author(s):  
Bruno Gagnon ◽  
Ioannis Gioulbasanis ◽  
Victor Cohen ◽  
Carmela Pepe ◽  
David I. Small ◽  
...  
Keyword(s):  
Lung Cancer ◽  
General Hospital ◽  
Risk Group ◽  
Prognostic Score ◽  
Performance Status ◽  
Risk Groups ◽  
Small Cell ◽  
Small Cell Lung ◽  
Stage Performance ◽  
The University

e18098 Background: For modern evidence-based medicine, a well defined risk scoring system on survival has important clinical implications for identifying patients with a poor prognosis. The objective of this study was to develop a Montreal Prognostic Score (MPS) based on risk scores of the baseline clinical markers. Methods: A training Cohort (TC) and confirmatory cohort (CC) of patients with non small-cell lung cancer were used to develop a Montreal Prognostic Score (MPS) and were assembled of patients from 3 different oncology centres: Jewish General Hospital in Montreal, Quebec, Canada; the University General Hospital of Heraklion Crete, Greece; and at the University General Hospital of Larissa, Greece. Stage, performance status, smoking status, CRP, Albumin, LDH and WBC from TC were entered in a Cox’s model on survival. Independent prognostic factors (p ≤ 0.1) were assigned a relative risk score by dividing their Proportional Hazard by the lowest one rounding to the closest integer. A 3 risk groups’ regression based total score (MPS) was finally developed by regrouping subgroups of patients with similar median survival. The MPS was tested on the CC. C-statistics was used to test the accuracy of the MPS. Results: 638 pts were included in the study: 314 in the TC and 324 in the CC. Majority of patients were stage 4 adenocarcinomas with good performance status treated with platinum-based chemotherapy. Stage, performance status, CRP, Albumin, LDH and WBC retained independent prognostic value and were used to create the MPS. The MPS predicted 3 well defined risk groups of patients with the following median survival and (95% CI) in months: high risk group (87 patients), 5.0 (4.2—7.0); intermediary risk group (98 patients), 9.6 (8.4—11.9); and low risk group (84 patients) 15.2 (12.4—25.1). When the MPS is applied to CC, the results were replicated for each risk group. Overall the TC had a C-stats of 0.673 (95% CI: 0.668, 0.679) while the CC of 0.702 (95% CI: 0.696, 0.708). Conclusions: We have developed a Montreal Prognostic Score based on stage, performance status and the baseline value of CRP, Albumin, LDH, WBC. This MPS has a high capacity of discriminating survival and might have wide implications in clinical practice and research.

Association between rigors and overall survival (OS) in metastatic renal cell carcinoma (mRCC) patients treated with high-dose interleukin-2 (HD IL-2).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 487-487
Author(s):  
Julia Anne Batten ◽  
Wolfram E. Samlowski ◽  
Kinjal Parikh ◽  
Arun Sendilnathan ◽  
Hilda Crispin ◽  
...  
Keyword(s):  
Overall Survival ◽  
Proportional Hazards ◽  
Objective Response ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
High Dose ◽  
University Of Utah ◽  
Cox Proportional Hazards Models ◽  
Grade 3

487 Background: HD IL-2 is associated with an objective response rate of 16-20% with durability of response in select mRCC patients. HD IL-2 is also associated with significant toxicity including vascular leak syndrome and inflammatory side effects. Few predictive markers can identify patients likely to respond to HD IL-2. Methods: Patients treated with HD IL-2 at the University of Utah Huntsman Cancer Institute from 2000 to 2012 with clear cell mRCC were evaluated. Grade of toxicities during HD IL-2 treatment were collected based on provider documentation in the electronic health record. Rates of adverse events (AEs) and overall survival stratified grade 3 AEs were evaluated by Kaplan-Meier survival estimates and Cox proportional hazards models. All AEs were graded per common terminology criteria version 4. Grade 3 rigors were defined as severe rigors requiring opioids. Results: A total of 85 patients were included with a median age of 56 years (range 32-76 years) and 79% (n = 67) were male. Patients belonged to the following MSKCC risk categories: 11 (13%) good, 70 (82%) intermediate, and 4 (5%) poor risk. The mean total dose received was 1097 MIU (range: 160 – 3048 MIU). The prevalence of grade 3 AEs is presented in the table. Median survival of patients with ≥grade 3 rigors after HD IL-2 administration was 1501 days vs 533 days for those without (p = 0.0005, HR 2.54). Presence of rigors was also associated with a significant improvement in progression free survival, time to next treatment and response rates. No other AEs predicted response to HD IL-2. Conclusions: Presence of grade 3 rigors predicts improved survival during HD IL-2 therapy. Notably, grade 3 fever was rarely observed because of our institutional protocol of routinely using scheduled antipyretics to diminish fevers. [Table: see text]

Clinical characteristics and treatment outcomes of patients (pts) with advanced germ cell tumor (aGCT) treated at a tertiary cancer center in Brazil.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 568-568
Author(s):  
Vitor Fiorin de Vasconcellos ◽  
Diogo Assed Bastos ◽  
Allan Andresson Lima Pereira ◽  
Bruno Rodriguez Pereira ◽  
Jamile Almeida Silva ◽  
...  
Keyword(s):  
Germ Cell ◽  
Treatment Outcomes ◽  
Performance Status ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Developed Countries ◽  
Cancer Center ◽  
High Dose ◽  
Ecog Performance Status ◽  
Poor Risk

568 Background: Reported treatment outcomes for pts with aGCT are largely based on series from developed countries. Data from less developed countries are lacking. Methods: From 2000 to 2015, a retrospective analysis identified 302 pts with aGCT treated at Instituto do Cancer do Estado de São Paulo (ICESP). Kaplan-Meier methods were used for analysis of progression-free survival (PFS) and overall survival (OS) according to the International Germ Cell Consensus Classification Group (IGCCCG). Results: Median follow-up was 46 months and median age was 28 years old. Clinical features and management are detailed in the Table. 54 pts (18%) had ECOG performance status (PS) ≥ 2 at baseline. According to the IGCCCG, 57% were good-, 18.3% intermediate-, and 24.7% poor-risk disease. Median AFP was 2.9, 243, and 3.998 and HCG was 0.4, 113 and 301 in IGCCCG good-, intermediate-, and poor-risk groups, respectively. 5-year PFS and OS were 69% and 85%, respectively, including 83% and 95.3% in good-risk, 70.9% and 83.6% in intermediate-risk and 35.1% and 62.2% in poor-risk pts. Only 3 pts (3%) received high-dose chemotherapy (HDCT) as first salvage therapy. Conclusions: Brazilian pts with advanced GCT in this cohort had similar outcomes as pts in the IGCCCG database. In comparison to contemporary series, pts with intermediate- and poor-risk GCT had slightly inferior PFS and OS, possibly due to a high percentage of pts with poor PS and less use of HDCT. [Table: see text]

Phase II Trial of the Bonn Polychemotherapy Protocol with Deferred Radiotherapy in Patients with Primary Central Nervous System Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2453-2453
Author(s):  
Ingo G.H. Schmidt-Wolf ◽  
Annika Juergens ◽  
Hendrik Pels ◽  
Axel Glasmacher ◽  
Holger Schulz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Central Nervous System Lymphoma ◽  
Response Duration ◽  
Complete Response ◽  
High Dose ◽  
Survival Fraction ◽  
Median Response ◽  
Kaplan Meier ◽  
Time To Treatment Failure

Abstract Objectives: The trial was performed to evaluate response rate, response duration, overall survival, and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intraventricular chemotherapy with deferred radiotherapy. Patients and Methods: From 09/1995 to 12/2002, 88 patients with PCNSL (median age 62 years) were enrolled onto a pilot/phase II study evaluating chemotherapy without radiotherapy. A high-dose methotrexate (MTX) (cycles 1,2,4,5) and cytarabine (ara-C) (cycles 3,6) based systemic therapy (including dexamethasone, vinca-alkaloids, ifosfamide and cyclophosphamide) was combined with intraventricular MTX, prednisolone and ara-C. Primary endpoint was time to treatment failure (TTF), secondary endpoints were response, overall survival, response duration, 5-year-survival fraction and (neuro)toxicity. Results: Eighty-four of 88 patients were evaluable for response. Of these, 46 (54%) achieved complete response (CR), 4 (5%) complete response/unconfirmed, 8 (10%) partial response (PR), and 14 (17%) progressed under therapy. Seven (8%) out of 84 patients died due to treatment-related complications. In five (6%) of 84 patients therapy had do be discontinued due to severe treatment related complications. Follow-up is one to 124 months (median 42 months). Kaplan Meier estimates for median time to treatment failure (TTF), median overall survival and median response duration are 19 months, 55 months and 37 months respectively. For patients aged 60 years or older, the respective numbers were 9 months, 34 months and 24 months; in patients younger than 60 years Kaplan Meier estimate for TTF is 49 months, median overall survival and median response duration have not been reached yet. The 5-year survival fraction is 72% in patients < 60 years and 24% in older patients. Systemic toxicity was mainly hematologic. Ommaya reservoir infection occurred in 20 (23%) patients. In a subgroup of patients (n=23) treated with chemotherapy alone serial neuropsychological testing showed no chemotherapy related cognitive decline in any patient. However, 8 out of 13 documented elderly patients treated with cranial irradiation as salvage therapy developed severe cognitive deficits. Conclusions: Primary chemotherapy based on high-dose MTX and ara-C is highly efficient in PCNSL. A substantial fraction of patients < 60 years can obviously be cured with this regimen.

Randomized Comparison of Standard Induction with Daunorubicin (DNR) for 3 Days vs Idarubicin (IDA) for 3 or 4 Days in AML pts Aged 50 to 70 and of Maintenance with Interleukin 2. Final Analysis of the ALFA 9801 Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 162-162 ◽  
Author(s):  
Cecile Pautas ◽  
Xavier Thomas ◽  
Fatiha Merabet ◽  
Emmanuel Raffoux ◽  
Jean Henri Bourhis ◽  
...  
Keyword(s):  
Interleukin 2 ◽  
Final Analysis ◽  
Risk Groups ◽  
Salvage Chemotherapy ◽  
Phase Iii ◽  
High Dose ◽  
Duration Of Hospitalization ◽  
High Doses ◽  
Grade 3 ◽  
To Receive

Abstract Background: For many years the ALFA Group has used high dose DNR, i.e 80 mg/m2/day for 3d as part of the induction regimen for untreated adult AML pts. As the equivalence of DNR and Ida is not known we conducted a phase III study to compare high dose DNR to Ida. We also tested the effect of IL2 for maintenance. Methods: Newly diagnosed AML, aged 50 to 70 years, were randomized to receive AraC 200 mg/m2/day IV x 7 d with either DNR: 80 mg/m2/d x 3 d (arm 1) or Ida: 12 mg/m2/d x 3 d (arm 2) or x 4 d (arm 3). Pts who failed could receive a salvage course with Mitoxantrone x 2 d and AraC1g/m2 12 hrs x 4d. Response was assessed after induction+/− salvage chemotherapy. CR pts received 2 consolidation courses according to the induction arm with DNR: 80 mg/m2 or Ida:12 mg/m2 for 1 day (first course) or 2 days (2nd course) and AraC:1g/m2/12 hrs x 4 days. Pts in CCR after the two consolidation courses were randomized to receive or not a maintenance immunotherapy with IL2: 5.106/m2 for 5 days monthly for12 months. Results: From 2001 to 2006, 468 pts were included (median age: 60 years). The 3 treatment arms were well matched for pretreatment characteristics. CR was achieved in 360/468 pts (77%): 109 (70%) pts arm 1, 129 (83%) arm 2, 122 (78%) arm 3 (p=0.02).70 pts, (45%) pts in the DNR arm reached CR after 1 course vs 97 (62%) and 90 (57%) in Ida arms (p= 0.006). Pts in Ida arms experienced more grade 3 or 4 mucositis (p=0.004) but no differences were observed between the 3 arms for duration of hospitalization, time to PMN or plts recovery, incidence of grade 3 or 4 infectious episodes and treatment related mortality. 3 year cumulative incidence of relapse was 69%, 63%, 62% resp in arms 1,2,3 (p=NS). 3 year EFS was 19%, 30%, 26% resp (p=0.06 for arm 1 vs arms 2 and 3). 3 year OS was 31%, 40% 41% resp in arms 1,2,3 (p=NS). Age (&lt; or &gt;60 years), sex, initial WBC counts, initial LDH (nl or &gt;nl), DNR or Ida arms, need for a salvage course were not predictive for relapse, while 2yCIR was 43%, 64%, 77% among respectively fav, intermediate and unfav cytogenetic risk groups resp (p=0.0046). Of the 219 pts alive in CR after consolidations, 161 (73%) were randomized for maintenance. Only 22 of the 77 pts randomized for IL2 completed the 1 year treatment. 32 and 23 pts stopped IL2 resp because of relapse or intolerance. There were no differences in relapse or OS in both maintenance arms. Conclusion: Ida treatment even when compared to high doses of DNR yields higher CR rate and more CR after one course. This effect translated in slightly better EFS but not better CIR or OS. IL2 maintenance treatment at least as scheduled in this trial was difficult to apply and showed no impact on disease course.

Adjuvant radiotherapy for atypical meningiomas

2016 ◽  
Vol 126 (6) ◽  
pp. 1822-1828 ◽  
Author(s):  
Hilary P. Bagshaw ◽  
Lindsay M. Burt ◽  
Randy L. Jensen ◽  
Gita Suneja ◽  
Cheryl A. Palmer ◽  
...  
Keyword(s):  
Adjuvant Radiotherapy ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Initial Therapy ◽  
Rank Test ◽  
University Of Utah ◽  
Simpson Grade ◽  
Kaplan Meier ◽  
First Recurrence ◽  
Atypical Meningiomas

OBJECTIVEThe aim of this paper was to evaluate outcomes in patients with atypical meningiomas (AMs) treated with surgery alone compared with surgery and radiotherapy at initial diagnosis, or at the time of first recurrence.METHODSPatients with pathologically confirmed AMs treated at the University of Utah from 1991 to 2014 were retrospectively reviewed. Local control (LC), overall survival (OS), Karnofsky Performance Status (KPS), and toxicity were assessed. Outcomes for patients receiving adjuvant radiotherapy were compared with those for patients treated with surgery alone. Kaplan-Meier and the log-rank test for significance were used for LC and OS analyses.RESULTSFifty-nine patients with 63 tumors were reviewed. Fifty-two patients were alive at the time of analysis with a median follow-up of 42 months. LC for all tumors was 57% with a median time to local failure (TTLF) of 48 months. The median TTLF following surgery and radiotherapy was 180 months, compared with 46 months following surgery alone (p = 0.02). Excluding Simpson Grade IV (subtotal) resections, there remained an LC benefit with the addition of radiotherapy for Simpson Grade I, II, and III resected tumors (median TTLF 180 months after surgery and radiotherapy compared with 46 months with surgery alone [p = 0.002]). Patients treated at first recurrence following any initial therapy (either surgery alone or surgery and adjuvant radiotherapy) had a median TTLF of 26 months compared with 48 months for tumors treated at first diagnosis (p = 0.007). There were 2 Grade 3 toxicities and 1 Grade 4 toxicity associated with radiotherapy.CONCLUSIONSAdjuvant radiotherapy improves LC for AMs. The addition of adjuvant radiotherapy following even a Simpson Grade I, II, or III resection was found to confer an LC benefit. Recurrent disease is difficult to control, underscoring the importance of aggressive initial treatment.

scholarly journals Randomized Study of High-Dose and Low-Dose Interleukin-2 in Patients With Metastatic Renal Cancer

2003 ◽  
Vol 21 (16) ◽  
pp. 3127-3132 ◽  
Author(s):  
James C. Yang ◽  
Richard M. Sherry ◽  
Seth M. Steinberg ◽  
Suzanne L. Topalian ◽  
Douglas J. Schwartzentruber ◽  
...  
Keyword(s):  
Overall Survival ◽  
Low Dose ◽  
Performance Status ◽  
Randomized Study ◽  
Cell Cancer ◽  
Interleukin 2 ◽  
Complete Response ◽  
High Dose ◽  
Metastatic Renal Cancer ◽  
Survival Difference

Purpose: This three-arm randomized study compares response rates and overall survival of patients with metastatic renal cell cancer (RCC) receiving high-dose or one of two low-dose interleukin-2 (IL-2) regimens. Patients and Methods: Patients with measurable metastatic RCC and a good performance status were randomized to receive either 720,000 U/kg (high-dose [HD]) or 72,000 U/kg (low-dose [LD]), both given by intravenous (IV) bolus every 8 hours. After randomly assigning 117 patients, a third arm of low-dose daily subcutaneous IL-2 was added, and an additional 283 patients were randomly assigned. Results: A total of 156 patients were randomly assigned to HD IV IL-2, and 150 patients to LD IV IL-2. Toxicities were less frequent with LD IV IL-2 (especially hypotension), but there were no IL-2-related deaths in any arm. There was a higher response proportion with HD IV IL-2 (21%) versus LD IV IL-2 (13%; P = .048) but no overall survival difference. The response rate of subcutaneous IL-2 (10%, partial response and complete response) was similar to that of LD IV IL-2, differing from HD IV (P = .033). Response durability and survival in completely responding patients was superior with HD IV compared with LD IV therapy (P = .04). Conclusion: Major tumor regressions, as well as complete responses, were seen with all regimens tested. IL-2 was more clinically active at maximal doses, although this did not produce an overall survival benefit. The immunological factors which constrain the curative potential of IL-2 to only a small percentage of patients need to be further elucidated.

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