Surgery Combined With Peritonectomy Procedures and Intraperitoneal Chemohyperthermia in Abdominal Cancers With Peritoneal Carcinomatosis: A Phase II Study

Purpose: To evaluate the tolerance of peritonectomy procedures (PP) combined with intraperitoneal chemohyperthermia (IPCH) in patients with peritoneal carcinomatosis (PC), a phase II study was carried out from January 1998 to September 2001. Patients and Methods: Fifty-six patients (35 females, mean age 49.3) were included for PC from colorectal cancer (26 patients), ovarian cancer (seven patients), gastric cancer (six patients), peritoneal mesothelioma (five patients), pseudomyxoma peritonei (seven patients), and miscellaneous reasons (five patients). Surgeries were performed mainly on advanced patients (40 patients stages 3 and 4 and 16 patients stages 2 and 1) and were synchronous in 36 patients. All patients underwent surgical resection of their primary tumor with PP and IPCH (with mitomycin C, cisplatinum, or both) with a closed sterile circuit and inflow temperatures ranging from 46° to 48°C. Three patients were included twice. Results: A macroscopic complete resection was performed in 27 cases. The mortality and morbidity rates were one of 56 and 16 of 56, respectively. The 2-year survival rate was 79.0% for patients with macroscopic complete resection and 44.7% for patients without macroscopic complete resection (P = .001). For the patients included twice, two are alive without evidence of disease, 54 and 47 months after the first procedure. Conclusion: IPCH and PP are able to achieve unexpected long-term survival in patients with bulky PC. However, one must be careful when selecting the patients for such an aggressive treatment, as morbidity rate remains high even for an experienced team.

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IMCT-08ReACT: LONG-TERM SURVIVAL FROM A RANDOMIZED PHASE II STUDY OF RINDOPEPIMUT (CDX-110) PLUS BEVACIZUMAB IN RELAPSED GLIOBLASTOMA

Neuro-Oncology ◽

10.1093/neuonc/nov218.08 ◽

2015 ◽

Vol 17 (suppl 5) ◽

pp. v109.1-v109 ◽

Cited By ~ 17

Author(s):

David A. Reardon ◽

Annick Desjardins ◽

James Schuster ◽

David D. Tran ◽

Karen L. Fink ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Term Survival ◽

Long Term Survival ◽

Randomized Phase Ii

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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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Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a randomized phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.15_suppl.3501 ◽

2015 ◽

Vol 33 (15_suppl) ◽

pp. 3501-3501 ◽

Cited By ~ 32

Author(s):

Theo Ruers ◽

Cornelis J. A. Punt ◽

Frits van Coevorden ◽

Jean-Pierre Pierie ◽

Inne Borel Rinkes ◽

...

Keyword(s):

Radiofrequency Ablation ◽

Liver Metastases ◽

Phase Ii ◽

Colorectal Liver Metastases ◽

Phase Ii Study ◽

Term Survival ◽

Long Term Survival ◽

Randomized Phase Ii ◽

Unresectable Colorectal Liver Metastases

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Repeated anti-CEA-radioimmunotherapy (RAIT) with 131iodine-labetuzumab after resection of colorectal liver metastases (CLM): Long-term results of a prospective phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.719 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 719-719

Author(s):

Kia Homayounfar ◽

Carsten O. Sahlmann ◽

Martin Niessner ◽

Johannes Meller ◽

Lena-Christin Conradi ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Long Term Results ◽

Hematological Toxicity ◽

R0 Resection ◽

Term Survival ◽

Salvage Resection ◽

Metastatic Relapse ◽

Experienced Grade

719 Background: Previously, single anti-CEA-radioimmunotherapy (RAIT) with 131iodine(I)-labetuzumab after complete (R0) resection of CEA-positive CLM was well tolerated and improved overall survival (OS) compared to a control group without RAIT. In this phase II study, we examined safety, feasibility, and long-term efficacy of repeated RAIT in the same setting. Methods: After R0-resection of CEA-positive CLM, 63 pts (42 m, 21 f; median age, 64.5 yrs) with synchronous (n=33) or metachronous (n=30) CLM received RAIT with 40-50 mCi/m2 per dose. 45 pts were intermediate/high risk for early metastatic relapse according to the Fong score. Restaging with CT/MRI and FDG-PET was performed prior to each RAIT. Pts with persistent elevated serum CEA-levels or inconclusive lesions during post-operative restaging received RAIT, but were classified as “non-adjuvant.” Toxicity was classified according to NCI-CTC v2.0. Time to progression (TTP), OS and cancer-specific survival (CSS) were calculated. The median follow-up was 54 (range 6-127) mos. Results: After the first cycle of RAIT 14 of 63 pts experienced grade 4 hematological toxicity. Nineteen pts did not receive the second cycle of RAIT due to prolonged toxicity, impaired performance status (n=6), or metastatic relapse (n=13). The latter were further treated by resection (n=3) or systemic chemotherapy (n=10). Forty-four pts received the planned second cycle of RAIT. Of these, 4 pts newly experienced grade 4 hematological toxicity. For all 63 pts, the median TTP, OS and CSS were 13, 57 and 92 months, respectively. The truly “adjuvant” pts (n=39) had a an improved median TTP (26 vs. 6.6 mos, p<0.0001), OS (76 vs. 42 mos, p=0.03) and CSS (not reached vs. 42 mos, p=0.003) in comparison to “non-adjuvant” pts (n=24). Conclusions: Repeated anti-CEA-RAIT with 131I-labetuzumab is safe, feasible, and well-tolerated (100% compliance), with expected hematological toxicity. The long-term survival after RAIT is very encouraging, in particular for pts deemed truly “adjuvant” post-salvage resection of CLM at restaging prior to RAIT.

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Long-Term Survival in Metastatic Melanoma Patients Treated with Sequential Biochemotherapy: Report of a Phase II Study

Cancer Investigation ◽

10.1080/07357900600817758 ◽

2006 ◽

Vol 24 (5) ◽

pp. 474-478 ◽

Cited By ~ 6

Author(s):

B. Neri ◽

L. Vannozzi ◽

C. Fulignati ◽

P. Pantaleo ◽

D. Pantalone ◽

...

Keyword(s):

Metastatic Melanoma ◽

Phase Ii ◽

Phase Ii Study ◽

Term Survival ◽

Long Term Survival ◽

Melanoma Patients

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Abstract P1-14-09: Long term survival of locally advanced breast cancers (LABC) treated with neoadjuvant treatment, results of a multicenter randomised phase II study (Remagus 02 trial)

10.1158/1538-7445.sabcs15-p1-14-09 ◽

2016 ◽

Author(s):

S Giacchetti ◽

A-S Hamy-Petit ◽

S Delaloge ◽

E Brain ◽

F Berger ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Locally Advanced ◽

Neoadjuvant Treatment ◽

Advanced Breast ◽

Breast Cancers ◽

Treatment Results ◽

Term Survival ◽

Long Term Survival

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Imatinib plus hydroxyurea in pretreated nonprogressive glioblastoma (GBM): Long-term follow up of a single-center phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e13004 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e13004-e13004

Author(s):

Gregor Paul Dresemann

Keyword(s):

Dose Reduction ◽

Phase Ii ◽

Survival Data ◽

Phase Ii Study ◽

Progression Free Survival ◽

Continuous Treatment ◽

Term Survival ◽

Cell Counts

e13004 Background: GBM is malignant brain tumour with a median survival of 15.6 months. Dysregulated signalling of platelet derived growth factor receptors is suggested to play a role in pathogenesis. The combination of imatinib (I) plus hydroxyurea (HU) is known to be well tolerated and to show moderate efficacy in patients (pts) with recurrent GBM. Despite the aggressive course of GBM once starting progression, short periods of disease stabilisation after primary treatment or effective treatment of relapse can be observed. This Phase II study was initiated to analyse the efficacy of I plus HU as maintenance treatment (MT) in GBM pts. Methods: From December 2003 up to June 2005 30 pts were included. No enzyme-inducing anticonvulsive drugs were allowed. I (600 mg/day) and HU (1000 mg/day) were given as a continuous treatment. Blood cell counts were taken weekly and magnetic resonance imaging every 6 weeks. Primary endpoint (PE) was 6 and 12 months progression free survival (PFS), secondary endpoints (SE) were 5 years PFS and overall survival (OS). Results: All pts were eligible for PE and SE. 25 pts were male, 5 pts female, median age was 44 years (32 to 71). All pts had prior irradiation, 21 pts had prior temozolomide (T) containing therapy and 9 pts non-temozolomide containing therapy. 8 pts had none, 17 pts one and 5 pts two prior relapses. 25 pts had measurable disease, 4 of these pts achieved a partial response (PR), there was no complete remission, 5 pts had no evidence of disease. Median follow up is 90 months. Hematotoxicity grade 2 and 3 occurred in 11 out of 30 pts and required dose reduction of HU in 8 pts, dose reduction of I in 1 patient and G-CSF in 8 pts. PFS rate at 6, 12, 24 and 60 months were 60% (18/30), 40% (12/30), 17% (5/30) and 17% (5/30 ) respectively, OS rate at 6, 12, 24 and 60 months were 90% (27/30), 67% (20/30), 37% (11/30) and 17% (5/30). 4 pts are still alive without progression. Conclusions: Although I and HU did not demonstrate relevant efficacy in GBM and never reached admission status the reported study indicates impressive long-term survival data for I and HU as a continuous oral MT. Further studies should analyse more effective drugs like temozolomide as MT (proof of principle). Clinical trial information: STI571DE21.

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