Intraperitoneal recombinant alpha-2-interferon alternating with cisplatin as salvage therapy for minimal residual-disease ovarian cancer: a phase II study.

1990 ◽  
Vol 8 (6) ◽  
pp. 1036-1041 ◽  
Author(s):  
M Nardi ◽  
F Cognetti ◽  
C F Pollera ◽  
M D Giulia ◽  
A Lombardi ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Phase Ii ◽  
Salvage Therapy ◽  
Potential Role ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Positive Cytology ◽  
Chemical Peritonitis

A phase II study was initiated in March 1987 at the Regina Elena National Cancer Institute of Rome to evaluate the efficacy of alternating intraperitoneal (IP) recombinant alpha-2-interferon (r-alpha 2-IFN) and cisplatin (DDP) as salvage therapy for less than or equal to 5 mm residual-disease (RD) ovarian carcinoma. Fourteen assessable patients entered the study. All had received prior chemotherapy (11 with DDP-based regimens); five patients had macroscopic RD (less than or equal to 5 mm), and nine had microscopic RD (histologically positive random biopsies and/or positive cytology and immunocytochemical tests). The response to IP immunochemotherapy was evaluated by laparotomy. Pathologic complete remissions (PCRs) were achieved in seven patients (50%) who have remained free of disease with a median follow-up of 22+ months (range, 11+ to 30+ months). Six patients achieved a stable disease and one presented disease progression. With the exception of chemical peritonitis-induced adhesions, no limiting toxicity was observed. The results obtained in this small, highly selected series demonstrate that a high PCR rate may be obtained with IP immunochemotherapy with DDP and r-alpha 2-IFN as salvage therapy in residual ovarian carcinoma less than or equal to 5 mm after first-line chemotherapy also including intravenous (IV) DDP. Larger comparative studies must be conducted to establish the potential role of IP DDP and r-alpha 2-IFN as compared with either of the single treatments.

Long-Term Complete Molecular Remissions in Untreated Symptomatic Follicular Lymphoma Treated with Rituximab as Single Agent and in Combination with Interferon-alpha-2a: Analysis of Minimal Residual Disease in the Randomized Phase II Study M39035.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1393-1393
Author(s):  
Jesper Jurlander ◽  
Christian Geisler ◽  
Hans Hagberg ◽  
Harald Holte ◽  
Tuula Lehtinen ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Minimal Residual Disease ◽  
Interferon Alpha ◽  
Phase Ii ◽  
Residual Disease ◽  
Phase Ii Study ◽  
First Year ◽  
Minimal Residual

Abstract From 9/98 to 11/99, 126 patients with symptomatic previously untreated or first relapse (< 6 months of chlorambucil and/or local radiotherapy) CD20+ low-grade lymphoma, were included in a multicenter randomised phase II study. The treatment consisted of a first cycle of rituximab 375 mg/sqm q wk x 4. Pts in CR at week 14 were observed with no further treatment until symptomatic relapse, while pts with SD or PD went off study. Pts with PR or minor response were randomised to receive either a second cycle of rituximab 375 mg/sqm q wk x 4 or interferon-alpha-2a (IFN) 3 MIU/day sc (wk 1), 4,5 MIU/day (wk 2–5) in combination with rituximab 375 mg/sqm q wk (w 3–6). The clinical data from this study has previously been reported (Kimby E, et al. Ann Oncol2002;13 (Suppl 2):85). 38 patients (30%) fulfilled the criteria for CR, and were eligible for analysis of minimal residual disease (MRD). 14 more patients achieved CR at a time point later than first follow up after end of treatment. Per protocol, these patients are not included in the present analysis. By standard DNA-based PCR, presence of either a t(14;18) fusion transcript (MCR/mbr) or a clonal rearrangement of the Ig heavy chain (CDR3) could be detected in the diagnostic bone marrow and blood sample from 23 patients. These patients have now been studied for MRD, with a median follow-up time of 62 months. In dilution experiments the sensitivity of the assays was between 1:10−3 and 1:10−4. A given sample was considered negative if the PCR reaction was negative in three independent experiments, using up to 2 μg of template DNA. Patients were tested in blood and bone marrow at 10–16 weeks, 38–40 weeks and 52 weeks following treatment. A total of 175 samples, including 49 samples from patients in continued CR up to 5 years after treatment, have been analysed. Of 72 paired blood and bone marrow samples, only three showed inconsistency between blood and bone marrow, all three being positive in bone marrow and negative in blood. The frequency of MRD negativity 10–16 weeks after treatment was 4/9 (44%) in patients who received 1 cycle of rituximab, 3/5 (66%) in patients who received two cycles of rituximab and 7/9 (77%) in patients who received two cycles of rituximab with IFN priming. This trend towards a dose-response relation was however not significant, due to the small number of patients in each treatment group. The median duration of CR in patients who were negative at all three timepoints during the first year (n=14) was 62 months, compared to 21 months in patients (n=9) with one or more positive samples (p<0,005). At a median follow up of 62 months 9/14 patients who were MRD negative through the first year remain in complete molecular remission, compared to 1/9 patients who had one or more positive blood or bone marrow samples during the first year (p<0,03). Thus, sustained long-term complete molecular remissions are achievable with rituximab alone or in combination with IFN, and predictable by MRD status during the first year post treatment. Whether the quality of response is related to the dose of rituximab or the combination with IFN, and whether the response can be predicted using blood samples alone, must await the results of the ongoing ML16865 randomised phase III trial of rituximab vs IFN/rituximab in the same group of patients.

The Role of Liver Resection at the Time of Secondary Cytoreduction in Patients With Recurrent Ovarian Cancer

2014 ◽  
Vol 24 (1) ◽  
pp. 70-74 ◽  
Author(s):  
Valentin Kolev ◽  
Elena B. Pereira ◽  
Myron Schwartz ◽  
Umut Sarpel ◽  
Sasan Roayaie ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Survival Analysis ◽  
Liver Resection ◽  
Ovarian Carcinoma ◽  
Cytoreductive Surgery ◽  
Residual Disease ◽  
Recurrent Ovarian Cancer ◽  
Kaplan Meier

ObjectiveThe aim of this study is to determine the role of liver metastatectomy in the morbidity and survival of patients with recurrent ovarian carcinoma.MethodsWe retrospectively reviewed the records of all patients who had undergone hepatic resection for liver metastases from ovarian carcinoma at the time of cytoreductive surgery at our institution from 1988 to 2012. The Kaplan-Meier method was used for survival analysis. A total of 76 patients met the inclusion criteria and had undergone liver resection as part of cytoreductive surgery for ovarian carcinoma during the study period. Of these 76 patients, 27 underwent liver resection at the time of secondary cytoreduction, and these patients that are the focus of this analysis.ResultsMedian overall survival for the study group from the time of diagnosis to the last follow-up or death was 56 months (range, 12–249 months). Twenty died of the disease with an overall median survival of 12 months from the time of the liver resection (2–190 months), and 7 patients were alive with the disease at the time of the last follow-up. Based on Kaplan-Meier survival analysis, the factors associated with the longest survival after the liver resection (2–190 months) were the interval from the primary surgery of less than 24 months versus more than 24 months (P= 0.044) and secondary cytoreduction to residual disease of less than 1 cm (P= 0.014).ConclusionsBased on our analysis of a single institution’s series of ovarian cancer patients with hepatic metastasis, liver resection is feasible and safe and should be considered as an option in selected patients at the time of secondary cytoreduction.

scholarly journals O-0007 Exploratory Serum Biomarker Analyses from BO21129, a Phase II Study of Erlotinib in Second-Line Pancreatic Cancer: Potential Role of Amphiregulin?

2012 ◽  
Vol 23 ◽  
pp. iv7
Author(s):  
Michel Ducreux ◽  
Irina Davidenko ◽  
David Propper ◽  
Giovanni Gerardo Cardellino ◽  
Avgust Garin ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Potential Role ◽  
Phase Ii Study ◽  
Serum Biomarker ◽  
Second Line

scholarly journals Long term follow-up of a phase II study of cladribine with concurrent rituximab with hairy cell leukemia variant

2021 ◽  
Author(s):  
Dai Chihara ◽  
Evgeny Arons ◽  
Maryalice Stetler-Stevenson ◽  
Constance M Yuan ◽  
Hao-Wei Wang ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hairy Cell Leukemia ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Long Term Follow Up

Hairy cell leukemia variant (HCLv) responds poorly to purine analog monotherapy. Rituximab concurrent with cladribine (CDAR) improves response rate, but long-term outcomes are unknown. We report final results of a phase II study of CDAR for patients with HCLv. Twenty patients with 0-1 prior courses of cladribine and/or rituximab, including 8 previously untreated, received cladribine 0.15 mg/kg days 1-5 with 8 weekly rituximab doses 375 mg/m2. Patients received a 2nd rituximab course ≥6 months after cladribine, if/when minimal residual disease (MRD) was detected in blood. The complete remission (CR) rate from CDAR was 95%, 95% confidence interval (95%CI) 75-100%. Sixteen of 20 patients (80%, 95% CI: 56-94%) became MRD-negative by bone marrow at 6 months. The median duration of MRD-negative CR was 70.1 months and 7 of 16 are still MRD-negative up to 120 months. With median follow-up of 69.7 months, 11 patients received delayed rituximab and the 5-year progression-free survival (PFS) and overall survival (OS) were 63.3% and 73.9%, respectively. Five patients with TP53 mutations had shorter PFS (median: 36.4 months vs unreached, p=0.0024) and OS (median: 52.4 months vs unreached, p=0.032). MRD-negative CR at 6 months was significantly associated with longer PFS (unreached vs 17.4 months, p<0.0001) and OS (unreached vs 38.2 months, p<0.0001). Lack of MRD in blood at 6 months was also predictive of longer PFS and OS (p<0.0001). After progression following CDAR, median OS was 29.7 months. CDAR is effective in HCLv with better outcome in patients who achieved MRD-negative CR.

scholarly journals The Role of Surgery in Lung Cancer Treatment: Present Indications and Future Perspectives—State of the Art

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3711
Author(s):  
François Montagne ◽  
Florian Guisier ◽  
Nicolas Venissac ◽  
Jean-Marc Baste
Keyword(s):  
Lung Cancer ◽  
Residual Disease ◽  
State Of The Art ◽  
Locally Advanced ◽  
Small Cell Lung ◽  
Lung Cancers ◽  
Screening Programs ◽  
Systemic Therapies

Non-small cell lung cancers (NSCLC) are different today, due to the increased use of screening programs and of innovative systemic therapies, leading to the diagnosis of earlier and pre-invasive tumors, and of more advanced and controlled metastatic tumors. Surgery for NSCLC remains the cornerstone treatment when it can be performed. The role of surgery and surgeons has also evolved because surgeons not only perform the initial curative lung cancer resection but they also accompany and follow-up patients from pre-operative rehabilitation, to treatment for recurrences. Surgery is personalized, according to cancer characteristics, including cancer extensions, from pre-invasive and local tumors to locally advanced, metastatic disease, or residual disease after medical treatment, anticipating recurrences, and patients’ characteristics. Surgical management is constantly evolving to offer the best oncologic resection adapted to each NSCLC stage. Today, NSCLC can be considered as a chronic disease and surgery is a valuable tool for the diagnosis and treatment of recurrences, and in palliative conditions to relieve dyspnea and improve patients’ comfort.

scholarly journals A Narrative Review of Early Oral Stepdown Therapy for the Treatment of Uncomplicated Staphylococcus aureus Bacteremia: Yay or Nay?

2020 ◽  
Vol 7 (6) ◽  
Author(s):  
Michael Dagher ◽  
Vance G Fowler ◽  
Patty W Wright ◽  
Milner B Staub
Keyword(s):  
Staphylococcus Aureus ◽  
Hospital Readmission ◽  
Potential Role ◽  
Review Article ◽  
Narrative Review ◽  
Oral Antibiotics ◽  
Staphylococcus Aureus Bacteremia ◽  
Complete Treatment

Abstract Historically, intravenous (IV) antibiotics have been the cornerstone of treatment for uncomplicated Staphylococcus aureus bacteremia (SAB). However, IV antibiotics are expensive, increase the rates of hospital readmission, and can be associated with catheter-related complications. As a result, the potential role of oral antibiotics in the treatment of uncomplicated SAB has become a subject of interest. This narrative review article aims to summarize key arguments for and against the use of oral antibiotics to complete treatment of uncomplicated SAB and evaluates the available evidence for specific oral regimens. We conclude that evidence suggests that oral step-down therapy can be an alternative for select patients who meet the criteria for uncomplicated SAB and will comply with medical treatment and outpatient follow-up. Of the currently studied regimens discussed in this article, linezolid has the most support, followed by fluoroquinolone plus rifampin.

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