Hand-foot skin reaction (HFSR) and overall survival (OS) in the phase 3 RESORCE trial of regorafenib for treatment of hepatocellular carcinoma (HCC) progressing on sorafenib.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 412-412 ◽  
Author(s):  
Jordi Bruix ◽  
Philippe Merle ◽  
Alessandro Granito ◽  
Yi-Hsiang Huang ◽  
Gyorgy Bodoky ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Skin Toxicity ◽  
Phase 3 ◽  
Kaplan Meier ◽  
Baseline Factors ◽  
Baseline Characteristics ◽  
Hand Foot Skin Reaction ◽  
Grade 3 ◽  
Post Hoc ◽  
Clinical Trial Information

412 Background: Skin toxicity is a known adverse effect of multikinase inhibitors, and was shown to be a predictor of OS in patients (pts) with HCC treated with sorafenib (Reig M, 2014). In the RESORCE trial, regorafenib improved OS versus placebo in pts with HCC progressing on sorafenib (HR 0.62, 95% CI 0.50, 0.78; Bruix J, 2017). This retrospective analysis explored whether HFSR with regorafenib was associated with OS in RESORCE. Methods: Pts in RESORCE who were randomized to regorafenib 160 mg/day during the first 3 weeks of each 4-week cycle were divided into subgroups based on whether or not they had HFSR. Estimates of OS (95% CI) were calculated using the Kaplan–Meier method. Pts who were randomized, but not treated, were included in the no HFSR group for the analysis of survival. Results: Of 379 pts randomized, 374 received at least one dose of regorafenib. Of the treated pts, 53% (n = 199) had HFSR of any grade and 13% (n = 47) had grade 3 HFSR. Among pts with HFSR at any time during the study, 77% (n = 153) had the first HFSR event (any grade) during Cycle 1. Subgroups of pts with and without HFSR at any time had some imbalances in baseline characteristics (Table). OS was improved in pts who had HFSR at any time versus those who did not (Table). Pts who had a HFSR event during Cycle 1 also had improved OS versus those who did not (median OS 13.2 vs 8.5 months; HR 0.66, 95% CI 0.51, 0.86). Conclusions: In this post-hoc exploratory analysis, HFSR with regorafenib was associated with improved OS, as was previously shown for sorafenib. The potential confounding influence of baseline factors requires further investigation. Clinical trial information: NCT01774344. [Table: see text]

Hand-foot skin reaction (HFSR) and outcomes in the phase 3 CORRECT trial of regorafenib for metastatic colorectal cancer (mCRC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3551-3551 ◽  
Author(s):  
Axel Grothey ◽  
Liping Huang ◽  
Andrea Wagner ◽  
Eric Van Cutsem
Keyword(s):  
Progression Free Survival ◽  
Correct Trial ◽  
Phase 3 ◽  
Treatment Benefit ◽  
Multikinase Inhibitor ◽  
Cutaneous Toxicity ◽  
Kaplan Meier ◽  
Baseline Factors ◽  
Grade 3 ◽  
Post Hoc

3551 Background: Cutaneous toxicity is a known adverse effect of multikinase inhibitors and has been associated with clinical outcomes (Granito 2016). In the phase 3 CORRECT trial (NCT01103323), the multikinase inhibitor regorafenib significantly improved overall survival (OS) vs placebo in patients with mCRC (hazard ratio [HR] 0.77, 95% CI 0.64, 0.94; 1-sided P = 0.0052). This retrospective analysis explored whether HFSR was associated with outcomes in CORRECT. Methods: Patients randomized to receive regorafenib 160 mg/day during the first 3 weeks of each 4-week cycle were divided into subgroups based on whether or not they had HFSR. Estimates of OS and progression-free survival (PFS) (95% CI) were calculated using the Kaplan–Meier method. Patients who were randomized, but not treated, were included in the no HFSR group for the analysis of survival. Results: Of the 505 randomized patients, 500 received at least one dose of regorafenib. Among the treated patients, 47% (n = 235) had HFSR of any grade and 17% (n = 83) had HFSR grade 3. Of the patients who had HFSR, 69% (n = 162) had their first HFSR event (any grade) during the first treatment cycle. There was some imbalance in baseline characteristics between groups (Table). Survival was improved in patients who had HFSR at any time vs those who did not (Table). The OS benefit was also observed in patients who had the first HFSR event during Cycle 1 vs those who did not (median OS 7.2 vs 5.7 months; HR 0.66, 95% CI 0.51, 0.87). Conclusions: This post-hoc exploratory analysis suggests that patients who had HFSR had a greater treatment benefit from regorafenib. Since HFSR and survival are post-baseline assessments, results may be confounded by baseline factors or other unknown factors. Clinical trial information: NCT01103323. [Table: see text]

Time to grade ≥3 adverse events in pts receiving trifluridine/tipiracil (TAS-102).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 788-788 ◽  
Author(s):  
Eric Van Cutsem ◽  
Atsushi Ohtsu ◽  
Natividad Lopez Busto ◽  
Akira Kanehisa ◽  
Ronan Fougeray ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rest Period ◽  
Outpatient Setting ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Safety Population ◽  
End Of Treatment ◽  
Grade 3 ◽  
Post Hoc ◽  
Clinical Trial Information

788 Background: The phase 3 RECOURSE showed that treatment with trifluridine/tipiracil in patients (pts) with refractory metastatic colorectal cancer was associated with significantly improved survival versus placebo (7.1 versus 5.3 months, respectively; HR for death 0.68, 95% CI 0.58–0.81, p < 0.001), with few serious adverse events. Trifluridine/tipiracil is administered in 4-week cycles comprising 2 weeks with 5 days at 35 mg/m2 bid followed by 2 rest days, and then a 2-week rest period. Exploration of timing for AEs, particularly within the first cycle of treatment, is important for pt monitoring in the outpatient setting. Methods: We performed a post hoc analysis of the RECOURSE safety population (533 trifluridine/tipiracil; 265 placebo) to explore timing of hematological and nonhematological AEs. Results: Grade ≥ 3 adverse events (AEs) were more frequent with trifluridine/tipiracil than placebo for both hematological AEs (38% vs 0% neutropenia; 4% vs 0% febrile neutropenia; 18% vs 3% anemia; and 5% vs < 1% thrombocytopenia) and nonhematological AEs (2% vs 1% nausea; 2% vs < 1% vomiting; and 3% vs < 1% diarrhea). The median time to nadir in cycle 1 for hematological events was 28 days (17–31) for grade ≥ 3 neutropenia, 22 days (9–39) for grade ≥ 3 anemia, and 18 days (9–33) for grade ≥ 3 thrombocytopenia; similar values were obtained in subsequent cycles. The median times to nadir and values at nadir over the whole treatment duration (all cycles) are presented in the table for hematological and nonhematological AEs. Conclusions: Hematological and nonhematological AEs with trifluridine/tipiracil appear to be most intense towards the end of treatment cycles, which is reassuring for its use in the outpatient setting. Clinical trial information: NCT01607957. [Table: see text]

Subgroup analysis by prior lines of metastatic therapy (mtx) in NAPOLI-1: A global, randomized phase 3 study of liposomal irinotecan (nal-IRI) ± 5-fluorouracil and leucovorin (5-FU/LV), vs. 5-FU/LV in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed following gemcitabine-based therapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4127-4127
Author(s):  
Teresa Mercade Macarulla ◽  
Jens T. Siveke ◽  
Andrea Wang-Gillam ◽  
Chung-Pin Li ◽  
Gyorgy Bodoky ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Subgroup Analysis ◽  
Analysis Data ◽  
Ductal Adenocarcinoma ◽  
Phase 3 ◽  
Study Methodology ◽  
Liposomal Irinotecan ◽  
Grade 3 ◽  
Post Hoc ◽  
Clinical Trial Information

4127 Background: In the NAPOLI-1 study, nal-IRI+5-FU/LV significantly increased median OS vs. 5-FU/LV control (6.1 vs. 4.2 mo; unstratified HR = 0.67 [0.49–0.92]; p = .012). This is a subgroup analysis by prior lines of mtx. Methods: Study methodology has been published (Wang-Gillam; Lancet 2016). This exploratory subgroup analysis compares outcomes in pts with 0–1 vs. ≥2 prior mtx lines, based on primary survival analysis data (cut-off February 2014) of the ITT population. Results: OS, PFS and CA19-9 response rates in pts with 0–1 (65.8% of pts) or ≥2 (34.2%) prior mtx lines are shown (see Table). Median OS for nal-IRI+5-FU/LV improved vs. 5-FU/LV by 2.1 mo to 6.2 mo (HR = 0.66; p = .03) in pts with 0–1 prior mtx lines and by 1.1 mo to 5.4 mo (HR = 0.68; p = .18) in pts with ≥2 prior mtx lines. The safety profile was similar between subgroups with nal-IRI+5-FU/LV (≥grade 3 drug-related AEs: 43 [55%] with 0–1 and 20 [51%] with ≥2 prior mtx lines). Conclusions: This post-hoc subgroup analysis shows significant increases for nal-IRI+5-FU/LV over 5-FU/LV in OS, PFS and CA19-9 response in pts with 0–1 prior mtx lines. Median OS benefit was less prominent in later lines, but conclusions are restricted by limited pt numbers. Clinical trial information: NCT01494506. [Table: see text]

Outcome of second-line treatment (2L Tx) following nab-paclitaxel (nab-P) + gemcitabine (G) or G alone for metastatic pancreatic cancer (MPC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 333-333 ◽  
Author(s):  
David Goldstein ◽  
E. Gabriela Chiorean ◽  
Josep Tabernero ◽  
Robert Hassan El-Maraghi ◽  
Wen Wee Ma ◽  
...  
Keyword(s):  
Phase Iii ◽  
Line Treatment ◽  
Post Hoc Analysis ◽  
Superior Efficacy ◽  
Kaplan Meier ◽  
Baseline Characteristics ◽  
Metastatic Sites ◽  
Post Hoc ◽  
The Impact ◽  
Clinical Trial Information

333 Background: The impact of 2L Tx in MPC is not well described. The phase III MPACT trial (N = 861) demonstrated superior efficacy for nab-P + G vs G alone for 1L Tx of MPC. This post hoc analysis examined 2L Tx use in pts in MPACT. Methods: OS was estimated by the Kaplan-Meier method, using the most updated information from MPACT. Data were summarized by type of 2L Tx. Results: 347 pts received 2L Tx. Baseline characteristics (at start of 1L) of those pts were balanced between arms and representative of the ITT population: median age, 61-62 years; 12% had > 3 metastatic sites, and ≈ 30% had Karnofsky PS 70-80 in each arm. 26% and 14% of pts in the nab-P + G and G arms, respectively, discontinued 1L Tx for adverse events. OS in the 347 pts was significantly longer for nab-P + G vs G (Table). The median time from the end of 1L Tx to death for pts receiving no 2L Tx was 2.5 and 1.6 mo in the nab-P + G and G arms, respectively (HR, 0.67; P < 0.001), less than half for those who received any 2L Tx (5.3 and 4.5 mo). 78% and 76% of pts received a 5FU/capecitabine (cape)–containing regimen as 2L Tx after nab-P + G and G and achieved 13.5 and 9.5 mo of median OS, respectively. Conclusions: 2L Tx after nab-P + G or G alone in MPC is feasible and may potentially improve pt outcomes. Clinical trial information: NCT00844649. [Table: see text]

Ramucirumab (RAM) for sorafenib intolerant patients with hepatocellular carcinoma (HCC) and elevated baseline alpha fetoprotein (AFP): Outcomes from two randomized phase 3 studies (REACH, REACH2).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4073-4073 ◽  
Author(s):  
Josep M Llovet ◽  
Chia-Jui Yen ◽  
Richard S. Finn ◽  
Yoon-Koo Kang ◽  
Masatoshi Kudo ◽  
...  
Keyword(s):  
Objective Response ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Ecog Ps ◽  
Require Dose ◽  
Require Dose Adjustment ◽  
Clinical Trial Information

4073 Background: Oral multikinase inhibitors that have shown improvements in overall survival (OS) in HCC are associated with clinically important toxicities that commonly require dose adjustment or discontinuation (D/C) due to intolerance. REACH and REACH-2 studied RAM in patients (pts) with HCC who progressed on or were intolerant to sorafenib (SOR), and REACH-2 only enrolled pts with baseline AFP ≥400 ng/mL. In REACH-2 RAM treatment (trt) improved OS compared to placebo (P), supporting findings in REACH pts with baseline AFP ≥400 ng/mL. An exploratory analysis of outcomes by reason for D/C of SOR was performed. Methods: Pts had advanced HCC, Child-Pugh A, ECOG PS 0-1, and prior SOR. Pts were randomized to RAM 8 mg/kg or P Q2W. A pooled independent pt data analysis (stratified by study) of REACH-2 and REACH pts (AFP ≥400 mg/mL) was performed. Results are reported by reason for SOR D/C (intolerance or disease progression). OS and PFS were evaluated using Kaplan-Meier method and Cox proportional hazard model. Objective response rate (ORR), disease control rate (DCR) and safety are reported. Results: Baseline characteristics in the pooled population were generally balanced between trt arms in each subgroup. Median durations of prior SOR were 2.5 mo for SOR intolerant (n = 70) and 4.0 mo for SOR progressors (n = 472). Median OS (RAM v P) was 10.2 v 6.7 mo for SOR intolerant and 8.0 v 4.7 mo for SOR progressors (Table). Rates of D/C due to trt-related adverse events (AEs) (Table) (7% in each subgroup), and Grade ≥3 AEs (most frequently hypertension) were consistent with those observed in each study. Conclusions: Acknowledging limitations of sample size, the RAM trt benefit in SOR intolerant pts was consistent with that in the ITT population. RAM was well tolerated in SOR intolerant pts with low rates of D/C due to related-AEs. Clinical trial information: NCT01140347, NCT02435433. [Table: see text]

Impact of frontline doublet versus triplet therapy on clinical outcomes: Exploratory analysis from the RAINBOW study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4543-4543 ◽  
Author(s):  
Samuel J Klempner ◽  
Zev A. Wainberg ◽  
Kei Muro ◽  
Joseph Chao ◽  
Daniel V.T. Catenacci ◽  
...  
Keyword(s):  
Exploratory Analysis ◽  
Second Line ◽  
Role Functioning ◽  
Appetite Loss ◽  
Kaplan Meier ◽  
Common Prior ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Clinical Trial Information

4543 Background: Treatment (tx) of advanced gastric cancer (GC/GEJ) is highly heterogeneous, with substantial variability in tx patterns. Frontline tx choice may affect outcomes of subsequent tx, thereby influencing choice/efficacy of second-line (2L) tx. In RAINBOW, 2L ramucirumab(R) plus paclitaxel(P) significantly improved overall survival (OS) of patients (pts) with GC/GEJ. Here we explore efficacy, safety and quality of life (QoL) based on prior tx. Methods: Pts were grouped into doublet (DB) or triplet (TP) regimens based on prior cytotoxic tx received. OS and PFS were estimated using Kaplan-Meier method and tx effects on OS and PFS were evaluated by Cox PH model; safety and QoL were assessed descriptively for DB vs TP. Results: Use of DB and TP was similar between arms, with 23% in R+P and 26% in placebo (PB)+P arm receiving TP. Baseline characteristics were generally balanced between tx arms within DB and TP subgroups, with majority of TP administered in western regions (91%). Pts ≥65 years of age was 40% for DB and 28% for TP. DB pts (n = 498; 75%) received S1+cis (n = 97, 15%) and cape+ox (n = 71; 11%) as most common prior tx, while TP pts (n = 163; 25%) received epi+cape+ox (n = 74, 11%) and epi+cis+5FU (n = 53, 8%). Similar to ITT population, R+P improved OS and PFS in both DB and TP subgroups (Table). Patterns of overall and Grade ≥3 TEAEs between arms were similar regardless of prior tx. Higher rates of serious TEAEs were reported in TP pts (57%, 49%) than DB pts (44%, 40%) in R+P and PBO+P arms, respectively. Similar trend was observed for TEAEs leading to discontinuation for TP (40%, 30%) vs DB (29%, 22%) in respective tx arms. Baseline QoL scores were similar between tx arms within subgroups, but mean scores were > 5 points worse (range 0-100) for prior TP for role functioning, fatigue, pain, and appetite loss. Changes in mean scores were generally similar between arms and within subgroups. Conclusions: This exploratory analysis of RAINBOW suggests that although safety-related outcomes were less favorable in pts with prior TP, regardless of tx arm, similar improvements in efficacy were noted for R+P irrespective of prior DB or TP. Clinical trial information: NCT01170663 . [Table: see text]

Association between overall survival and adverse events with lenvatinib treatment in patients with hepatocellular carcinoma (REFLECT).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 317-317 ◽  
Author(s):  
Max W. Sung ◽  
Richard S. Finn ◽  
Shukui Qin ◽  
Kwang-Hyub Han ◽  
Kenji Ikeda ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Body Weight ◽  
Adverse Events ◽  
Actual Body ◽  
Actual Body Weight ◽  
Kaplan Meier ◽  
Post Hoc ◽  
To Receive ◽  
Clinical Trial Information

317 Background: In the phase 3 REFLECT study, lenvatinib (LEN) demonstrated a treatment effect on overall survival (OS) by statistical confirmation of non-inferiority to sorafenib (SOR) in patients (pts) with unresectable hepatocellular carcinoma (uHCC), who had not received prior treatment for advanced disease (Kudo M et al, Lancet 2018). Lenvatinib is approved in several major markets for the first line systemic treatment of uHCC. The most common adverse events (AEs) in pts treated with LEN were hypertension and diarrhea. In addition, LEN showed a different AE profile from that of SOR. Pts who received LEN experienced more instances of hypertension, proteinuria, dysphonia, and hypothyroidism than patients who received SOR. Recently, hypertension in LEN-treated pts with differentiated thyroid cancer was shown to be correlated with improved efficacy. Here we report the post hoc analysis exploring whether AEs associated with LEN were correlated with longer OS in REFLECT. Methods: 478 Pts were randomized to receive LEN (12 mg/d for actual body weight ≥ 60 kg or 8 mg/d for actual body weight < 60 kg). Subgroup analyses were conducted based on whether pts treated with LEN experienced any-grade AEs of interest (AEIs). OS was estimated by the Kaplan-Meier method. Results: The AEIs in pts treated with LEN were hypertension (42%), diarrhea (38%), proteinuria (24%), dysphonia (24%), and hypothyroidism (16%). OS was longer in pts who had several AEs of interest than in those who did not (table). Conclusions: In pts treated with LEN, the occurrence of hypertension, diarrhea, proteinuria, or hypothyroidism was generally associated with longer OS in pts with uHCC in this post hoc exploratory analysis. The potential confounding factors at baseline should be further investigated. Clinical trial information: NCT01761266. [Table: see text]

Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: An open-label, single-center, single-arm clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16117-e16117
Author(s):  
Jian-Xu Li ◽  
Ting-Shi Su ◽  
Xiao-Feng Lin ◽  
Yi-Tian Chen ◽  
Shi-Xiong Liang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Clinical Study ◽  
Cancer Staging ◽  
Advanced Hepatocellular Carcinoma ◽  
Single Center ◽  
Open Label ◽  
Grade 3 ◽  
Clinical Trial Information

e16117 Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: an open-label, single-center, single-arm clinical study Jian-Xu Li, Ting-Shi Su, Xiao-Feng Lin, Yi-Tian Chen, Shi-Xiong Liang, Bang-De Xiang; Guangxi Medical University Cancer Hospital, Nanning, China Abstract Research Funding: Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. Guangxi Medical and Health Appropriate Technology Development and Application Project (No. S2019039), Guangxi, China. Background: Based on the results of recent studies, the PD-1 monoclonal antibodies have been approved to treat the patients with advanced hepatocellular carcinoma (HCC) by the FDA. Radiation therapy (RT) can enhance responsiveness to PD-1 monoclonal antibody by potential mechanisms. A phase Ⅱa study was conducted to assess the safety and the efficacy of combining RT with anti-PD-1 for patients with advanced hepatocellular carcinoma. Methods: Patients with advanced HCC were eligible. Stereotactic body radiation therapy (SBRT) were adopted, and the dose of radiation were Dt-PGTV 30-50 Gy/10fractions. Camrelizumab (200mg) were given intravenously every 3 weeks since the first day of RT until disease progression, or intolerable toxicity. Adverse events (AEs) and objective response rate (ORR) were summarized to assess the safety and efficacy. Results: From April 2020 to November 2020, 17 patients were enrolled (median age 54, range 32-69). 15 (88%) patients were male. 14 (82%) had ECOG performance score of 0. All the patients had Child-Pugh score A. 16 patients staged as Barcelona Clinic Liver Cancer staging C or China Liver Cancer staging Ⅲ. Extrahepatic metastases were identified in 11 (65%) patients. 13 (77%) patients were Hepatitis B virus infected. 15 (88%) patients had previously 2 lines or more chemotherapy. 9 (53%) patients had Alpha-fetoprotein level≥400 ng/ml. The ORR was 47%. The best response assessed by RECIST 1.1 was partial response (8 patients). Four patients had grade 3 immune-related adverse events (irAEs), including increased aspartate aminotransferase and alanine transaminase (n =1)，decreased hemoglobin (n =1)，decreased platelet count (n =1)，decreased neutrophil count (n =1). All grade 3 irAEs were mitigated with proper treatment. None treatment-related deaths occurred. Conclusions: In this study, RT combined with anti-PD-1 had an acceptable safety profile and indicated an effective treatment option in patients with unresectable HCC. Clinical trial information: NCT04193696. Clinical trial information: NCT04193696.

Melphalan 200mg/m2 (MEL 200) and MEL 140/DT-PACE Are Equally Effective in Multiple Myeloma (MM), While the Latter Is Less Toxic.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 839-839 ◽  
Author(s):  
Guido Tricot ◽  
Maureen Reiner ◽  
Maurizio Zangari ◽  
Frits van Rhee ◽  
Bart Barlogie
Keyword(s):  
Febrile Neutropenia ◽  
Prior Therapy ◽  
Study Enrollment ◽  
Kaplan Meier ◽  
Rapid Responses ◽  
Preparative Regimen ◽  
Previously Treated ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Induction Cycle

Abstract MEL 200 is now generally accepted to represent the best preparative regimen for autotransplantation in MM patients. We have previously reported that DT-PACE is very effective in inducing rapid responses even in high risk myeloma (JCO 2003, 31: 73–80). The present study aimed at comparing outcome and toxicity of previously treated (≥ 2 cycles of prior therapy) MM patients, who were randomized to tandem transplants with either MEL 200 or MEL 140 plus full dose DT-PACE administered over two days (MEL/DT-PACE). The treatment in both arms consisted of one induction cycle with DT-PACE, followed by tandem transplants (randomized), one consolidation cycle with DT-PACE and 2 years of maintenance therapy with dexamethasone (20mg/d, days 1–4, every 3 weeks) plus thalidomide 100mg/day. 97 patients were enrolled; 93 collected sufficient stem cells for transplantation and were randomized to MEL 200 (N=48) or MEL140/DT-PACE (N=45). Event-free (EFS) and overall survival (OS) were analyzed using Kaplan-Meier plots. Graphs were compared with logrank statistics. Median age was 57 years. Prior to study enrollment β2M was ≥ 4mg/L in 28%; CRP ≥ 4 mg/L in 59%; LDH ≥ 250 U/L in 16%. 16% had &gt; 12 months preceding therapy and 27% showed abnormal metaphase cytogenetics. Baseline characteristics were similar in both groups, except for a trend of more patients with β2M ≥ 4mg/: in the MEL 200 arm (p=0.09). 100% of randomized patients proceeded to the first transplant and 82% to a second; 87% in the MEL/DT-PACE and 77% in the MEL 200 arm (p=0.23). The CR rates were identical (44% and 42%, respectively). EF/OS at 3 years were 51%/71% in the MEL/DT-PACE arm and 55%/79% in the MEL 200 arm (p=.89/.73) (Figure 1). Recovery of ANC &gt; 500μl plus platelets &gt; 20,000/μl untransfused, was comparable after the first (p=0.21) and second transplant (p=0.17). Grade 3–5 toxicity was lower in the MEL/DT-PACE arm in terms of mucositis (p=.006) and febrile neutropenia (p=.001). We conclude that both preparative regimens, MEL 200 and 140 with the addition of DT-PACE, appear equally effective in previously treated MM patients. However, the Mel 140 resulted in a significantly lower incidence of mucositis and febrile neutropenia and may thus be preferred in patients not in excellent clinical condition prio to transplantation. Figure Figure

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