This study was carried out to assess the efficacy of high-dose ifosfamide/mesna (HDIFM) in the treatment of advanced or recurrent cancer of the cervix. In all, 18/21 evaluable patients with advanced or inoperable cervical cancer were included. The mean age was 42 years (range, 31-58 years); and the International Federation of Gynecology and Obstetrics (FIGO) stage was III in 10 patients and IV in 11. The Karnofsky performance status ranged between 70 and 90, with a median of 77. Ten patients had previously been treated with surgery, radium and cobalt (8) or cobalt alone (2). Therapy consisted of 3.5 g/m2, ifosfamide (IFO) given in an 8-h i.v. infusion on days 1-5 and mesna at 20% of the IFO dose, given i.v. at 0, 2, 4, 6 and 8 h, followed by mesna at 40% of the IFO dose by the oral route at 10 and 12 h on days 1-5. For evaluation purposes, patients received at least two cycles. Toxicity was registered in 137 cycles and was mild to moderate. Three complete (16.6%) and six partial (33.3%) responses were observed (50%), but 66% of them occurred in areas that had not previously been irradiated. The median duration of response was 14 months and the overall median survival was 15+ months (18+ months for responders). The Karnofsky scale after treatment ranged from 90 to 100. The results of this study indicate that HDIFM is well tolerated, giving a high percentage of remission (50%) and significantly improving the quality of life.
Thirty patients with advanced squamous cell carcinoma of the cervix were included in a phase II study with cisplatin (DDP) and ifosfamide (IF)/mesna. They received a median of 4 courses of chemotherapy and were all evaluable for response and toxicity. Each cycle consisted of 2,500 mg/m2 IF i.v. days 1-5; mesna 500 mg/m2 i.v. at hours 0 and 2, and 1,000 mg/m2 per os at hours 6 and 10, days 1-5; DDP 20 mg/m2 i.v., days 1-5. Cycles were repeated every 4 weeks. One patient obtained CR and 14 PR giving an overall response rate of 50%. Mean duration of response was 21 months. Anemia grade 3 developed in 7 patients, leukopenia grade 3 in 9 patients and grade 4 in one patient; thrombopenia grade 3 in 2; creatinine clearance grade 3 in one; CNS grade 3 in one and cystitis grade 3 in one patient. Overall median survival time was about 25+ months (3-63+); after a follow-up of 70 months, 11 patients (37%) are still alive with a median survival of 31+ months. IF plus DDP seems to be a good combination for treatment of advanced cervical cancer, with acceptable tolerance and response rate.
Background:After the introduction of novel and more‐effective therapies in multiple myeloma (MM) the number of patients achieving high quality responses has substantially increased, demanding the implementation of more sensitive methods to evaluate persistence of minimal residual disease (MRD) in bone marrow (BM) at very low levels. We have recently developed the Next Generation Flow (NGF) approach to assess medullary MRD in MM patients, which became the reference methodology by the International Myeloma Working Group (IMWG) to evaluate flow‐MRD status. Despite the clinical prognostic value of NGF BM MRD, sampling is limited to (few) specific timepoints throughout therapy. Nowadays, more frequent and less‐invasive approaches are used for a closer follow‐up (e.g., serum immunofixation ‐sIF‐). More recently, NGF has successfully been applied for the detection of circulating tumor plasma cells (CTPC) in peripheral blood (PB) of plasma cells neoplasms patients at diagnosis, providing significant diagnostic and risk stratification information; however, the prognostic impact of PB CTPC detection in MM patients after therapy has not been deeply explored.Aims:Here, we investigated the value of NGF for PB CTPC detection in post‐therapeutic MM patients and its relationship with paired BM MRD and sIF evaluations.Methods:Overall, we studied 309 paired PB and BM samples from 128 treated MM patients discriminated according to the IMWG response criteria. Both PB and BM samples were processed using the EuroFlow NGF MM‐MRD approach in parallel to sIF. The Kaplan–Meier method and the log‐rank test were used to plot and compare progression‐free survival (PFS) curves between groups. PFS was defined as time from sample evaluation to either disease progression or death by any reason. For all statistical analyses the SPSS (v. 23; IBM, Armonk, NY), was used. Statistical significance was set at p values <0.05. Written informed consent was given by each patient prior to entering the study according to the Declaration of Helsinki.Results:Altogether, 26% of all MM analyzed (33/128) showed CTPC+ in PB. In turn, 49/128 (38%) of patients were BM MRD+ without CTPC in PB. Of note, CTPC were never detected in PB in the absence of BM involvement (n = 0/128). In addition, sIF+ results were present in close to one third of patients without PB CTPC (39/128; 30%), and 26% (10/39) of them being BM MRD−. Focusing on complete response (CR) or stringent CR (sCR) MM patients (i.e, sIF−; n = 65), 17% (11/65) were PB CTPC+. Median percentages and absolute CTPC counts in PB were significantly lower for those CR/sCR MM patients than observed in the whole cohort of CTPC+ cases (p < 0.05): 0.0002% (range: <0.0001%>0.007%) and 15 CTPC/mL of PB (range: <5–457 CTPC/mL) vs 0.002% (range: <0.0001%>0.6%) and 96 CTPC/mL of PB (range: <5–18,352 CTPC/mL), respectively. Noteworthy, from the prognostic point of view, MM patients who were PB CTPC+ showed significantly shorter PFS rates vs PB CTPC− cases regardless of BM‐MRD status, both in the whole patient series and within CR/sCR patients (median PFS of 11 months vs not reached, respectively; p<0.0001 in both comparisons).Summary/Conclusion:The high‐sensitive NGF approach allowed detection of PB CTPC in more than a quarter MM cases after treatment and in 17% of those in CR/sCR. Detection of PB CTPC identified a poor prognostic subgroup of patients (≈80% of relapse or death at 2 years). In summary, NGF can be applied in PB for non‐invasive monitoring of post‐therapeutic MM patients and provides complementary prognostic value to BM MRD and sIF.image
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