Photodynamic therapy in patients with non-resectable hilar cholangiocarcinoma: 5-year follow-up of a prospective phase II study

4124 Background: This study reports the final analysis (n=50) of a prospective phase II study evaluating the efficacy of the combination of sorafenib and doxorubicin eluting bead transarterial chemoembolization (DEB-TACE) in patients with unresectable hepatocellular carcinoma (HCC). Methods: Protocol consisted of 6-week cycles with sorafenib at 800 mg/day beginning 1 week prior to DEB-TACE; up to 4 DEB-TACE treatments within 6 months. Tumor response was assessed by RECIST and EASL criteria using MRI at baseline and at 1 month follow-up. Time to untreatable progression (TTUP) was defined as the interval from initiation of sorafenib therapy until inability of patient to further receive intra-arterial therapy. Overall survival (OS) and TTUP were calculated with the Kaplan-Meier method; outcomes were stratified by BCLC A/B and C and compared with the log-rank test. Results: DEB-TACE + sorafenib successfully performed in 50 patients: mean 62yrs (range, 31-88 yrs), Child-Pugh A/B (92%/8%), BCLC A/B/C (10%/28%/62%), ECOG 0/1 (52%/48%), HCV/HBV (44%/8%), mean tumor burden 20%, mean tumor size 7.2cm (range, 1–17.6), and mean tumor enhancement 78%. Patients were enrolled for a median of 3 (range, 1-22) cycles including a median of 1 (range, 0-6) DEB-TACE procedure. Median dose regimen was 400mgQD and the median dose taken while on study was 318 mg/day (range, 100-800). 1 month follow-up showed a mean tumor enhancement reduction of 48.2% (n=46, p<0.001) and an average reduction in lesion diameter of 8.5%(n=48, p=0.02). The Disease Control Rate was 98% using the EASL amendment and RECIST. Median TTUP was 11.9 mths (95% CI, 1.8-22 mths) with a significant difference between BCLC A/B (median 22.9 mths) and BCLC C (median 6.2mths) patients (log-rank, p=0.01). Median OS was 24.5 mths (95% CI, 14.3-35 mths) with a significant difference between BCLC C (median 17.1 mths) and BCLC A/B (median 33.7 mths) patients (log-rank, p=0.001). Conclusions: The results of this phase II study suggest a potential benefit to the combination of sorafenib and DEB-TACE. Single arm and non-randomization are limitations of the study. Clinical trial information: NCT00844883.

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Long-term follow-up of the GELA LNH 03-7B study: A prospective phase II study of 150 patients over 80 years with diffuse large B-cell lymphoma (DLBCL) treated with RminiCHOP.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.8536 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 8536-8536 ◽

Cited By ~ 1

Author(s):

Frederic Peyrade ◽

Olivier Fain ◽

Bettina Fabiani ◽

Frederic Bauduer ◽

Eric Van Den Neste ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

B Cell Lymphoma ◽

Response To Treatment ◽

Disease Stage ◽

Term Survival ◽

Old Patients ◽

Prospective Phase

8536 Background: We report the outcome of patients included in the LNH 03-7B prospective phase II study of the GELA group which evaluated the tolerance and efficacy of a reduced dosage chemotherapy regimen (miniCHOP) associated with full dose rituximab in patients aged over 80 years with DLBCL. Methods: Patients were between 80 and 95 years (median 83 years), had disease stage I Bulky to IV and 65% had poor risk lymphoma according to IPI. Perfomance status was 0-2 in all cases. The majority of deaths and grade III/IV toxicity occurred during cycle 1 and 2. Response to treatment and early survival analyses were previously presented with 20 months median follow-up (Lancet oncol 2011;12:460-468). Results: At the time of this analysis, The median follow-up time was 41 months and 75 (50%) patients were alive. The 4-year estimated overall survival (OS) was 49.3% [95% CI: 40.8-57.3%] and the median OS was 38 months. The 4-year estimated PFS, EFS and DFS were 41.4% [95% CI: 33.1-49.5%], 39.4% [95% CI : 31.2-47.5%] and 57.9% [95% CI : 47.3-67.2%] respectively.]. During the additional follow-up, 8 patients relapsed (10% of CR patients) and 17 died. No long term toxicity was recorded. In a multivariate analysis an albumin level >35 g/l remained significantly associated with a longer survival. Conclusions: These results show that very old patients with DLBCL treated with RminiCHOP could express long-term survival and probably be cured. Regarding the DFS and despite the early toxicity, it seems crucial to obtain the best possible response. This long term analysis confirm that in patient aged over 80y with DLBCL and with PS from 0 to 2, RminiCHOP is the treatment cornerstone. Clinical trial information: NCT01087424.

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Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study

Hepatology ◽

10.1002/hep.27905 ◽

2015 ◽

Vol 62 (5) ◽

pp. 1456-1465 ◽

Cited By ~ 18

Author(s):

Andrej Wagner ◽

Ulrike W. Denzer ◽

Daniel Neureiter ◽

Tobias Kiesslich ◽

Andreas Puespoeck ◽

...

Keyword(s):

Photodynamic Therapy ◽

Biliary Tract ◽

Phase Ii ◽

Phase Ii Study ◽

Biliary Tract Carcinoma ◽

Prospective Phase

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A Prospective Phase II Study on Tandem Autografting-Nonmyeloablative Allografting for Newly Diagnosed Myeloma: Final Results of the Gruppo Italiano Trapianto Midollo Osseo.

Blood ◽

10.1182/blood.v110.11.3026.3026 ◽

2007 ◽

Vol 110 (11) ◽

pp. 3026-3026

Author(s):

B. Bruno ◽

M. Rotta ◽

F. Patriarca ◽

D. Mattei ◽

B. Allione ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Chronic Gvhd ◽

New Drugs ◽

Newly Diagnosed ◽

Disease Response ◽

Post Transplant ◽

Primary Endpoints ◽

Prospective Phase

Abstract The development of nonmyeloablative conditionings has recently reduced the transplant-related mortality (TRM) and extended the eligible age for transplantation up to 65–70 years. From January 2000 to June 2005, 106 newly diagnosed patients younger than 65 years were enrolled in a prospective phase II study at 15 Italian Centers. Fifty-eight were also previously described in a comparison of autografting with allografting based on a genetic randomisation (Bruno et al. N Engl J Med 2007). Here we report on a larger GITMO experience with a longer follow-up. Induction chemotherapy consisted of VAD-based regimens, followed by a cytoreductive autograft with melphalan 200 mg/m2, and by a non-myeloablative 2 Gy TBI-based allograft from an HLA-identical sibling. Graft-vs-host disease (GVHD) prophylaxis included cyclosporin and mycophenolate mofetil. Primary endpoints were overall (OS) and event-free (EFS) survivals. Secondary endpoint was TRM. One-hundred-two (96%) patients, median age 54 (30–65), completed the tandem program whereas 4 withdrew their consent. After a median follow-up of 54 (21–94) months, OS was not reached and median EFS was 35 (31–56) months post-transplant. Incidences of acute grade II-IV GHVD and extensive chronic GVHD were 40% and 50% respectively. Fourteen (13%) patients died from TRM, 14 (13%) from disease progression, 2 from lung cancer (2%) and 1 from lymphoma (1%). Overall response, defined as complete (CR) and partial remission, was 91% (93/102), with 53 patients achieving CR. Overall 39/102 patients relapsed, however only 8/53 of those who reached CR post-transplant. By multivariate-analysis disease response prior to allografting was significantly associated with longer OS (HR 0.27, CI 0.09–0.80, p<0.018) and longer EFS (HR 0.23, CI 0.11–0.49, p<0.001). Interestingly, chronic GVHD was not correlated with either the achievement of post-transplant CR (HR 0.87, CI 0.45–1.65, p<0.66) or its duration (HR 0.79, CI 0.45–1.40, p<0.42). Presence of del(13) was evaluated only in a subset of 39 patients: 13 carried del(13) and 26 did not. OS was not reached in the patients without del(13) and was 52 months in patients with del(13) (p=0.32), however EFS was not reached in the patients without del(13) whereas was 27 months for patients with del(13) (p=0.04). Given the encouraging results, the design of prospective studies that incorporate new drugs to cytoreduce the disease pre-transplant and enhance graft-vs.-myeloma are warranted to lower relapse rates and improve clinical outcomes.

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