Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy.

4522 Background: Prognostic factors for overall survival (OS) in patients receiving second-line chemotherapy for advanced platinum-pretreated UC include ECOG performance status (PS) >0, hemoglobin (Hb) <10g/dL and the presence of liver metastasis (LM) (Bellmunt J, J Clin Oncol 2010). We hypothesized that time from prior chemotherapy (TFPC) independently impacts OS. Methods: Of 11 available phase II trials evaluating second-line therapy for advanced UC (n=698), 6 trials with available baseline Hb, PS and LM were utilized (n=534). The trials evaluated vinflunine (2 trials), docetaxel plus vandetanib or placebo, paclitaxel-gemcitabine, nanoparticle-albumin-bound paclitaxel and paclitaxel-cetuximab. The Kaplan-Meier method was used to estimate OS from date of starting second-line therapy. Cox proportional hazards regression stratified for trial was used to evaluate the prognostic effect of factors on OS. TFPC was evaluated as a continuous variable, and based on cutpoints of 3, 6, 9 and 12 months (mo) from prior chemotherapy to first study treatment. The choice of optimal cutpoint for TFPC was determined by the maximum likelihood ratio χ2 statistic. Results: Overall, 513 patients were evaluable. 64.1% received prior chemotherapy for metastatic disease. Median OS was 6.8 mo (95% CI: 6.1 to 7.4); range was 0 to 84.2 mo. Median OS was 5.2, 7.1, 8.8, 7.6 and 10.6 mo respectively for TFPC <3 (n=181), 3 to <6 (n=133), 6 to <9 (n=77), 9 to <12 (n=45) and >12 (n=77) mo, respectively. Shorter TFPC was independently prognostic for decreased survival. The optimal cutpoint for TFPC was <3 mo, but no well-defined plateau was observed. PS>0 (HR=1.72, p<0.001), LM (HR=1.41, p=0.002), Hb <10 g/dl (HR=1.59, p=0.001) and TFPC <3 mo (HR=1.67, p<0.001) were significantly prognostic in the multivariate model. Timing of prior chemotherapy (metastatic disease vs. perioperative) was not prognostic. Conclusions: A shorter duration of TFPC exhibited a significant negative prognostic impact on OS independent of known prognostic factors in patients receiving second-line therapy for advanced UC. If externally validated, TFPC should be a stratification factor in trials of second-line therapy for advanced UC.

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Impact of response to prior chemotherapy (RTPC) on outcomes in second-line therapy for advanced urothelial carcinoma (UC): Implications for trial design.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.4539 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 4539-4539

Author(s):

Gregory Russell Pond ◽

Joaquim Bellmunt ◽

Ronan Fougeray ◽

Toni K. Choueiri ◽

Angela Q. Qu ◽

...

Keyword(s):

Metastatic Disease ◽

Multivariable Analysis ◽

Prognostic Impact ◽

Second Line ◽

Phase Ii Trials ◽

Second Line Therapy ◽

Prior Chemotherapy ◽

Prior Therapy ◽

Line Therapy ◽

The Impact

4539 Background: Performance status (PS), hemoglobin (Hb), liver metastasis (LM), and time from prior chemotherapy (TFPC) are significant prognostic factors in second-line therapy for advanced UC. Setting of prior chemotherapy, i.e., metastatic or perioperative, has not appeared significant. However, the impact of prior chemosensitivity is unclear, which may confound trial interpretation. Hence, we examined the prognostic impact of RTPC, when prior therapy was given for metastatic disease. Methods: Six phase II trials evaluating second-line chemotherapy and/or biologics (n=504) were pooled. Patients who received prior therapy for metastatic disease were eligible for analysis if data regarding Hb, LM, PS, and TFPC were available. Response by RECIST to first-line therapy was recorded. Progression-Free Survival (PFS) and overall survival (OS) were calculated from the date of registration using the Kaplan-Meier method. Results: 275 pts were evaluable for analysis. Patients received gemcitabine-paclitaxel, cyclophosphamide-paclitaxel, pazopanib, docetaxel plus vandetanib/placebo or vinflunine (2 trials). Those with prior response (n=111) had a median (95% CI) OS of 8.0 (6.8-9.4) months (mo) and PFS of 3.0 (2.6-4.0), compared with OS and PFS of 5.9 (5.0-6.6) mo and 2.6 (2.0-2.8) for those without prior response (n=164). Multivariable analysis did not reveal an independent impact of RTPC on PFS or OS (Table). Conclusions: RTPC in patients receiving prior chemotherapy for metastatic disease did not confer an independent prognostic impact with second-line therapy for advanced UC. Patients who received prior chemotherapy in peri-operative or metastatic settings may be enrolled in the same second-line trial stratified for PS, anemia, LM and TFPC. [Table: see text]

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Nomogram to estimate the activity of second-line therapy for advanced urothelial carcinoma (UC).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.4524 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 4524-4524

Author(s):

Guru Sonpavde ◽

Gregory Russell Pond ◽

Neeraj Agarwal ◽

Toni K. Choueiri ◽

Angela Q. Qu ◽

...

Keyword(s):

Prognostic Factors ◽

Phase Ii ◽

Performance Status ◽

Phase Iii ◽

Second Line ◽

Phase Ii Trials ◽

Second Line Therapy ◽

Ecog Performance Status ◽

Line Therapy ◽

The Impact

4524 Background: Prognostic factors may impact on endpoints used in phase II trials of second-line therapy for advanced UC. We aimed to study the impact of prognostic factors (liver metastasis [LM], anemia [Hb<10 g/dl], ECOG-performance status [PS] ≥1, time from prior chemotherapy [TFPC]) on PFS6 and RR. Methods: Twelve phase II trials evaluating second-line chemotherapy and/or biologics (n=748) in patients with progressive disease were pooled. PFS was defined as tumor progression or death from any cause. PFS6 was defined from the date of registration and calculated using the Kaplan-Meier method. RR was defined using RECIST 1.0. A nomogram predicting PFS6 was constructed using the RMS package in R (www.r-project.org). Results: Data regarding progression, Hb, LM, PS and TFPC were available from 570 patients. The mean age was 65.1 years, 45.3% had ECOG-PS ≥1, 30.2% had LM, 14.6% had anemia and TFPC was <6 months (mo) in 60.2%. The overall median PFS was 2.7 mo, PFS6 was 22.2% (95% CI: 18.8-25.9) and RR was 17.5% (95% CI: 14.5%-20.9%). For every unit increase in risk group, the hazard of progression increased by 41% and the odds of response decreased by 48% (Table). A nomogram was constructed to predict PFS6 on an individual patient level. Conclusions: PFS6 and RR vary as a function of prognostic factors in patients receiving second-line therapy for advanced UC. A nomogram incorporating prognostic factors might facilitate the evaluation of activity across phase II trials enrolling heterogeneous populations and can help to select and stratify patients for phase III evaluation of suitable agents. [Table: see text]

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Impact of baseline prognostic factors on progression-free survival at 6 months (PFS6) and response in patients receiving second-line therapy for advanced urothelial carcinoma (UC).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.6_suppl.301 ◽

2013 ◽

Vol 31 (6_suppl) ◽

pp. 301-301 ◽

Cited By ~ 2

Author(s):

Gregory Russell Pond ◽

Neeraj Agarwal ◽

Joaquim Bellmunt ◽

Toni K. Choueiri ◽

Angela Q. Qu ◽

...

Keyword(s):

Prognostic Factors ◽

Phase Ii ◽

Risk Group ◽

Performance Status ◽

Second Line ◽

Phase Ii Trials ◽

Second Line Therapy ◽

Ecog Performance Status ◽

Line Therapy ◽

The Impact

301 Background: PFS6 was identified to be a robust intermediate endpoint in the setting of second-line therapy for advanced UC (Sonpavde, ESMO Congress, 2012) We studied the impact of second-line prognostic factors (Sonpavde, ESMO Congress 2012) (liver metastasis [LM], anemia [Hb<10 g/dl], ECOG-performance status [PS] ≥1, time from prior chemotherapy [TFPC]) on PFS6 and response rate (RR) to enable comparison of outcomes across phase II trials. Methods: Twelve phase II trials evaluating second-line chemotherapy and/or biologics (n=748) in patients with progressive disease were pooled. PFS was defined as tumor progression or death from any cause. PFS6 was defined from the date of registration and calculated using the Kaplan-Meier method. Results: Data regarding progression, Hb, LM, PS and TFPC were available in 570 patients, who were considered evaluable. The mean age was 65.1 years, 45.3% had ECOG-PS ≥1, 30.2% had LM, 14.6% had anemia and TFPC was <6 months (mo) in 60.2%. The overall median PFS was 2.7 mo, PFS6 was 22.2% (95% CI: 18.8-25.9) and RR was 17.5% (95% CI: 14.5%-20.9%). PFS6 and RR varied significantly according to risk group (Table). For every unit increase in risk group, the hazard of progression in 6 mo increased by 41% and the odds of response decreased by 48%. Conclusions: PFS6 and RR vary as a function of prognostic factors in patients receiving second-line therapy for advanced UC. These data facilitate comparison of outcomes across phase II trials enrolling heterogeneous populations. [Table: see text]

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Improved prognostic classification of patients receiving salvage systemic therapy for advanced urothelial carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.311 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 311-311 ◽

Cited By ~ 1

Author(s):

Guru Sonpavde ◽

Gregory Russell Pond ◽

Jonathan E. Rosenberg ◽

Dean F. Bajorin ◽

Ashley Marie Regazzi ◽

...

Keyword(s):

Prognostic Factors ◽

Urothelial Carcinoma ◽

Systemic Therapy ◽

Proportional Hazards ◽

Performance Status ◽

Risk Groups ◽

Cox Proportional Hazards ◽

Prognostic Impact ◽

Phase Ii Trials ◽

Advanced Urothelial Carcinoma

311 Background: Previously identified prognostic factors in patients (pts) receiving salvage systemic therapy for advanced urothelial carcinoma (UC) include performance status (PS), liver metastasis (LM), hemoglobin (Hb) and time from prior chemotherapy (TFPC). Given the prognostic impact of peripheral blood neutrophils (N), lymphocytes (L), thrombocytes (T) and albumin (Alb) in other malignancies, we investigated their impact in the salvage setting of advanced UC. Methods: Phase II trials of salvage systemic therapy were utilized. Data on N, L, T and Alb were required in addition to TFPC, Hb, PS and LM status. N, L, T and Alb were categorized as normal, <lower limit of normal (LLN) and >upper limit of normal (ULN). Cox proportional hazards regression was used to evaluate their association with overall survival (OS). An optimal regression model was constructed using forward stepwise selection and risk groups defined using number of identified adverse risk factors. Trial was a stratification factor. Results: Data was obtained from 10 trials accruing 708 pts. Of these, 682 pts had available TFPC, Hb, PS and LM status, while 631, 554, 649 and 491 had N, L, T and Alb available. Median OS was 6.8 (95% CI: 6.0-7.0) months. Neutrophilia (N>ULN), thrombocytosis (T>ULN) and hypoalbuminemia (Alb <LLN) were significant poor prognostic factors for OS on univariate analyses. After adjustment for TFPC <3 months, Hb <10 g/dl, PS >0 and LM status, only thrombocytosis and hypoalbuminemia remained significant (Table). Risk groups were constructed. Median OS was 8.8, 6.3, 5.0 and 3.8 months for n=290, 220, 123 and 49 patients with 0-1, 2, 3 and ≥4 factors. This 6-factor prognostic model was internally validated with an improvement in the c-index from 0.564 to 0.590. Conclusions: The addition of hypoalbuminemia and thrombocytosis to TFPC, Hb, PS and LM status enhanced the prognostic risk groupings in pts receiving salvage systemic therapy for advanced UC. [Table: see text]

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Sunitinib therapy for patients (pts) with metastatic renal cell carcinoma (mRCC): Updated results of two phase II trials and prognostic factor analysis for survival

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.5095 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 5095-5095 ◽

Cited By ~ 14

Author(s):

J. E. Rosenberg ◽

R. J. Motzer ◽

M. D. Michaelson ◽

B. G. Redman ◽

G. R. Hudes ◽

...

Keyword(s):

Prognostic Factors ◽

Treatment Plan ◽

Objective Response ◽

Time Interval ◽

Second Line ◽

Phase Ii Trials ◽

First Line ◽

Second Line Therapy ◽

Eligibility Criteria ◽

Line Therapy

5095 Background: Two single-arm phase 2 trials reported a 42% objective response rate (ORR) with sunitinib as second-line therapy in mRCC pts (JAMA 2006;295:2516–24). Efficacy results were updated and an analysis of prognostic factors for survival was performed on pooled data. Methods: Eligibility criteria and treatment plan were nearly identical for both trials. Pts with mRCC who failed =1 prior cytokine-based therapy received sunitinib in repeated 6-week cycles of 50 mg/day orally for 4 weeks, followed by 2 weeks off treatment. Response was assessed by investigators according to RECIST. Pretreatment clinical and biochemical features were examined for prognostic factors by univariate and multivariate analysis (p<0.05 significance level was used in the backward stepwise selection procedure). Results: Updated efficacy data for 168 evaluable pts showed an ORR of 45% (95% CI: 39%, 54%), median progression-free survival (PFS) of 8.4 months (95% CI: 7.9, 10.7), and median overall survival (OS) of 22.3 months (95% CI: 14.8, 36.0). Twenty pts remain on treatment with sunitinib with the longest pt on the drug for >3.5 years with partial response for >3 years. The median duration of response was 11.6 months (95% CI: 9.9, 15.2), and included 1 pt with a complete response for >2 years. The proportion of pts alive at 2 years is 48%. Final prognostic factors for survival in the multivariate model were ECOG PS 0 vs. =1 (p=0.0034); time interval from diagnosis to sunitinib treatment =1 yr vs. <1 yr (p=0.0002); hemoglobin =13 vs. <13 g/dL for males and =11.5 vs. <11.5 g/dL for females (p=0.0002). Conclusions: Median survival is nearly 2 years, which compares favorably to the historical experience (12.7 months) in second-line therapy with other agents (JCO 2004;22:454–63). The influence of sunitinib therapy on patient survival is being investigated in a randomized phase 3 trial compared to interferon-a in first-line therapy for mRCC. Further study of prognostic factors to sunitinib therapy is warranted in the first-line setting. No significant financial relationships to disclose.

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Impact of number of lines of prior chemotherapy in patients (pts) with advanced urothelial carcinoma (UC) receiving salvage therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.353 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 353-353 ◽

Cited By ~ 1

Author(s):

Guru Sonpavde ◽

Joaquim Bellmunt ◽

Jonathan E. Rosenberg ◽

Dean F. Bajorin ◽

Ashley Marie Regazzi ◽

...

Keyword(s):

Metastatic Disease ◽

Salvage Therapy ◽

Performance Status ◽

External Validation ◽

Multivariable Analysis ◽

Prognostic Impact ◽

Perioperative Chemotherapy ◽

Phase Ii Trials ◽

Prior Chemotherapy ◽

The Impact

353 Background: The prognostic impact of number of lines of prior chemotherapy and prior perioperative chemotherapy on survival results in salvage trials for advanced UC is unknown. Methods: We pooled 10 prospective phase II trials of salvage therapy for advanced UC with data on the number of prior lines of therapy in addition to known prognostic factors: TFPC (time from prior chemotherapy), Hb (hemoglobin), PS (performance status), and LM (liver metastasis) status. Cox proportional hazards regression was used to evaluate the association of number of prior lines with overall survival (OS) and progression-free survival (PFS). Trial was included as a stratification factor. Sub-analysis examined the impact of prior perioperative chemotherapy. Results: Of 731 pts, data for all factors was available for 711. The overall median PFS and OS were 2.7 and 6.8 months, respectively. Trials evaluated vinflunine (N=151), docetaxel +/- vandetanib (N=147), paclitaxel-gemcitabine (N=83), sunitinib (N=77), nab-paclitaxel (N=48), volasertib (N=46), everolimus (N=45), pazopanib (N=43), cetuximab +/-paclitaxel (N=39) and paclitaxel-cyclophosphamide (N=32). The number of prior lines of therapy were 1 in 559 (78.6%), 2 in 111 (15.6%), 3 in 29 (4.1%), 4 in 10 (1.4%) and 5 in 2 (0.3%) pts. Prior perioperative chemotherapy was given to 277 (39.1%) and chemotherapy for metastatic disease to 454 (64.1%) pts. While TFPC, Hb, PS and LM were significantly associated with OS and PFS on multivariate analyses, the number of prior lines was not associated with OS (HR 0.99 [95% CI: 0.86-1.14]) or PFS (0.92 [0.80-1.05]). Prior peri-operative chemotherapy was a favorable factor for both OS and PFS on univariable but not multivariable analysis. Conclusions: The number of prior lines of therapy and prior perioperative chemotherapy were not independently prognostic for OS or PFS in UC pts receiving salvage therapy, although the data are limited by few pts with >2 prior regimens. We infer that interpretation of OS and PFS results in salvage therapy trials will not be affected by inclusion of pts with ≥ 2 prior regimens including perioperative and/or metastatic disease treatment. These data need external validation.

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Impact of prior platinum agent and site of primary in patients with advanced urothelial carcinoma (UC) receiving salvage therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.336 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 336-336 ◽

Cited By ~ 1

Author(s):

Guru Sonpavde ◽

Joaquim Bellmunt ◽

Jonathan E. Rosenberg ◽

Dean F. Bajorin ◽

Ashley Marie Regazzi ◽

...

Keyword(s):

Prognostic Factors ◽

Salvage Therapy ◽

Performance Status ◽

Univariate Analysis ◽

External Validation ◽

Prognostic Impact ◽

Phase Ii Trials ◽

Prior Chemotherapy ◽

Platinum Agent ◽

Primary Bladder

336 Background: The prognostic impact of prior platinum agent (cisplatin vs. carboplatin) and site of primary (bladder vs. other) in the context of salvage therapy for advanced UC is unknown. Methods: We pooled 10 prospective phase II trials of ≥ second-line therapy for advanced UC with data recorded for prior platinum agent and site of primary in addition to major prognostic factors: TFPC (time from prior chemotherapy), Hb (hemoglobin), PS (performance status), and LM (liver metastasis) status. Cox proportional hazards regression was used to evaluate the association of prior platinum agent and site of primary with overall survival (OS) and progression-free survival (PFS). Trial was included as a stratification factor throughout. Kaplan-Meier method was used to estimate PFS and OS. Results: Of 731 patients overall, 559 had received one prior chemotherapy regimen, 663 were evaluable for prior platinum regimen and 512 for site of primary. The overall median PFS and OS were 2.7 and 6.8 months, respectively. The trials evaluated vinflunine (N=151), docetaxel +/- vandetanib (N=148), paclitaxel-gemcitabine (N=98), sunitinib (N=77), volasertib (N=50), nab-paclitaxel (N=48), everolimus (N=45), pazopanib (N=43), cetuximab +/-paclitaxel (N=39) and paclitaxel-cyclophosphamide (N=32). Prior platinum was cisplatin in 501 (75.6%) and carboplatin in the rest. Prior carboplatin was associated with worse OS on univariate analysis (HR 1.23 [1.00-1.52], P=0.048) but not significantly associated with either OS or PFS on multivariate analysis. Bladder was the site of primary in 388 (75.8%). The site of primary was not significantly associated with PFS and OS in either univariate or multivariate analyses. Conclusions: Neither prior platinum agent (cisplatin vs. carboplatin) nor site of primary (bladder vs. other) were independently associated with OS or PFS in patients receiving salvage therapy for advanced UC. Trials of salvage therapy may continue to utilize the previously recognized prognostic factors, and could allow patients with all sites of primary disease and regardless of the prior platinum agent. These data need external validation.

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Modified FOLFIRINOX as a second-line therapy following gemcitabine plus nab-paclitaxel therapy in metastatic pancreatic cancer

10.21203/rs.3.rs-18686/v4 ◽

2020 ◽

Author(s):

Masashi Sawada ◽

Akiyoshi Kasuga ◽

Takafumi Mie ◽

Takaaki Furukawa ◽

Takanobu Taniguchi ◽

...

Keyword(s):

Pancreatic Cancer ◽

Prognostic Factors ◽

Prognostic Model ◽

Prognostic Score ◽

Objective Response ◽

Metastatic Pancreatic Cancer ◽

Line Treatment ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy

Abstract Background There is no established second-line treatment after failure of gemcitabine plus nab-paclitaxel (GnP) therapy for metastatic pancreatic cancer (MPC). This study aimed to evaluate the efficacy and tolerability of the modified FOLFIRINOX (mFFX) as a second-line therapy for MPC and investigate prognostic factors for survival. Methods From 2015–2019, we retrospectively reviewed the medical records of patients receiving mFFX for MPC after failure of GnP therapy. Patients were treated every 2 weeks with mFFX (intravenous oxaliplatin 85 mg/m 2 , intravenous irinotecan 150 mg/m 2 , and continuous infusion of 5-fluorouracil 2,400 mg/m 2 for 46 hours without bolus infusion) until disease progression, patient refusal, or unacceptable toxicity. Results In total, 104 patients received mFFX. The median overall survival (OS) was 7.0 months (95% confidence interval [CI]: 6.2-9.8) and the progression-free survival (PFS) 3.9 months (95% CI 2.8-5.0). The objective response rate was 10.6% and the disease control rate 56.7%. The median relative dose intensities of oxaliplatin, irinotecan, and infusional 5-FU were 80.0% (range 21.5-100%), 77.2% (range 38.1-100%), and 85.9% (range 36.9-100%), respectively. Grade 3-4 toxicities were reported in 57 patients (54.8%), including neutropenia, leukopenia, anemia, febrile neutropenia, and peripheral sensory neuropathy. Glasgow prognostic score and carcinoembryonic antigen level were independently associated with survival. Our prognostic model using these parameters could classify the patients into good (n = 38), intermediate (n = 47), and poor (n = 19) prognostic groups. The median OS and PFS time was 14.7 (95% CI 7.6-16.3) and 7.6 months (95% CI 4.1-10.5) for the good prognostic factors, 6.5 (95% CI 5.5-10.0) and 3.6 months (95% CI 2.7-4.8) for the intermediate prognostic factors and 5.0 (95% CI 2.9-6.6) and 1.7 months (95% CI 0.9-4.3) for the poor prognostic factors, respectively. Conclusions The mFFX showed to be a tolerable second-line treatment for MPC after GnP failure. Our prognostic model might be useful for deciding whether mFFX is indicated in this setting.

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A phase III randomized intergroup trial (S0016) comparing CHOP plus rituximab with CHOP plus iodine-131-tositumomab for front-line treatment of follicular lymphoma: Results of subset analyses and a comparison of prognostic models.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.8001 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 8001-8001

Author(s):

Oliver W. Press ◽

Joseph M Unger ◽

Michael Leo LeBlanc ◽

Lisa M. Rimsza ◽

Jonathan W. Friedberg ◽

...

Keyword(s):

Regression Analysis ◽

Prognostic Factors ◽

Proportional Hazards ◽

Performance Status ◽

Cox Proportional Hazards ◽

Phase Iii ◽

Prognostic Models ◽

Prognostic Impact ◽

Prior Therapy ◽

Follicular Lymphomas

8001 Background: Advanced follicular lymphomas (FL) are considered incurable with chemotherapy and there is no consensus on the best treatment. Outcomes are variable, but can be partially predicted by defined prognostic factors. SWOG and CALGB compared the safety and efficacy of 2 immunochemotherapy regimens in a Phase III trial enrolling 554 patients between 3/1/2001 and 9/15/2008. Methods: Patients were eligible if they had bulky stage II, III or IV FL and had not received prior therapy. Patients randomized to CHOP-R received 6 cycles of CHOP every 21 days + 6 doses of rituximab. Patients randomized to CHOP-RIT received 6 cycles of CHOP, followed by consolidative radioimmunotherapy with tositumomab/iodine I-131 tositumomab. A Cox proportional hazards multi-variable regression analysis assessed the prognostic impact of age, stage, LDH, LN size and number, performance status, hemoglobin, β2 microglobulin, BM involvement, and B symptoms. The prognostic value of 3 multi-variable models were compared. Results: Outcomes were outstanding with either CHOP-R or CHOP-RIT (2 yr PFS: 76% vs 80% [ p =0.11]; 2 yr OS: 97% vs 93% [p =0.08], respectively). Subset analyses so far have not identified any subgroups clearly benefitting to a greater degree from CHOP-R or CHOP-RIT in terms of both PFS and OS. Cox multivariable regression analysis identified serum-β2M, LDH level, and FLIPI index as the strongest prognostic factors associated with worse PFS and OS. Conclusions: Both regimens produced outstanding PFS and OS, and no statistically significant differences between them were observed. FLIPI, FLIPI2, and LDH + β2M models were all strong predictors of patient outcomes. A combination of LDH + β2M was as good as the FLIPI index, and was simpler to apply. (Supported in part by NCI grants CA32102 and CA38926 from the NCI and GlaxoSmithKline.) [Table: see text]

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