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Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. Italian Study Group for the Di Bella Multitherapy Trails.

ABSTRACT: OBJECTIVE: To determine whether the treatment known as Di Bella multitherapy exerts antitumour activity worthy of further controlled clinical evaluation. DESIGN: 11 independent multicentre uncontrolled phase II trials relevant to 8 different types of cancer. SETTING: 26 Italian hospitals specialising in cancer treatment. SUBJECTS: 386 patients with advanced cancer were enrolled in the trials between March and July 1998 and followed to 31 October 1998. INTERVENTIONS: Melatonin, bromocriptine, either somatostatin or octreotide, and retinoid solution, the drugs that constitute Di Bella multitherapy, were given to patients daily. Cyclophosphamide and hydroxyurea were added in some trials. MAIN OUTCOME MEASURES: Responses were assessed every 1, 2, or 3 months, depending on the specific trial, and toxicity was evaluated using criteria developed by the World Health Organisation. RESULTS: No patient showed complete remission. Three patients showed partial remission: 1 of the 32 patients with non-Hodgkin's lymphoma; 1 of the 33 patients with breast cancer; and 1 of the 29 patients with pancreatic cancer. At the second examination, 12% (47) of the patients had stable disease; 52% (199) progressed; and 25% (97) died. CONCLUSIONS: Di Bella multitherapy did not show sufficient efficacy in patients with advanced cancer to warrant further clinical testing.

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PROVIDER: S-EPMC27702 | biostudies-literature | 1999 Jan

REPOSITORIES: biostudies-literature

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Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. Italian Study Group for the Di Bella Multitherapy Trails.

BMJ (Clinical research ed.) 19990101 7178

<h4>Objective</h4>To determine whether the treatment known as Di Bella multitherapy exerts antitumour activity worthy of further controlled clinical evaluation.<h4>Design</h4>11 independent multicentre uncontrolled phase II trials relevant to 8 different types of cancer.<h4>Setting</h4>26 Italian hospitals specialising in cancer treatment.<h4>Subjects</h4>386 patients with advanced cancer were enrolled in the trials between March and July 1998 and followed to 31 October 1998.<h4>Interventions</h ...[more]

PMID: 9915729

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Project description:BackgroundColon cancer is a disease with a worldwide spread. Surgery is the best option for the treatment of advanced colon cancer, but some aspects are still debated, such as the extent of lymphadenectomy. In Japanese guidelines, the gold standard was D3 dissection to remove the central lymph nodes (203, 213, and 223), but in 2009, Hoenberger et al. introduced the concept of complete mesocolic excision, in which surgical dissection follows the embryological planes to remove the mesentery entirely to prevent leakage of cancer cells and collect more lymph nodes. Our study describes how lymphadenectomy is currently performed in major Italian centers with an unclear indication on the type of lymphadenectomy that should be performed during right hemicolectomy (RH).MethodsCoDIG 2 is an observational multicenter national study that involves 76 Italian general surgery wards highly specialized in colorectal surgery. Each center was asked not to modify their usual surgical and clinical practices. The aim of the study was to assess the preference of Italian surgeons on the type of lymphadenectomy to perform during RH and the rise of any new trends or modifications in habits compared to the findings of the CoDIG 1 study conducted 4 years ago.ResultsA total of 788 patients were enrolled. The most commonly used surgical technique was laparoscopic (82.1%) with intracorporeal (73.4%), side-to-side (98.7%), or isoperistaltic (96.0%) anastomosis. The lymph nodes at the origin of the vessels were harvested in an inferior number of cases (203, 213, and 223: 42.4%, 31.1%, and 20.3%, respectively). A comparison between CoDIG 1 and CoDIG 2 showed a stable trend in surgical techniques and complications, with an increase in the robotic approach (7.7% vs. 12.3%).ConclusionsThis analysis shows how lymphadenectomy is performed in Italy to achieve oncological outcomes in RH, although the technique to achieve a higher lymph node count has not yet been standardized. Trial registration (ClinicalTrials.gov) ID: NCT05943951.

Dataset Information

Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. Italian Study Group for the Di Bella Multitherapy Trails.

Publications

Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. Italian Study Group for the Di Bella Multitherapy Trails.

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