Is restaging surgery quintessential in suspected early-stage epithelial ovarian cancer? An ancillary study of the Gynecologic Oncology Research Investigators coLLaborAtion study (GORILLA-3002).

To explore the impact of 2009 International Federation of Gynecology and Obstetrics (FIGO) staging system alteration for stage I endometrioid adenocarcinoma on its' prognosis assessing. A retrospective study was carried out on 244 cases with endometrial carcinoma admitted in Peking University People's Hospital from Jan.1995 to Feb.2008. (1) All 244 patients were divided into FIGO 2009 Ia group (n = 200) and FIGO 2009 Ib group (n = 44) according to FIGO 2009 staging system, while they were divided into FIGO 1988 Ia group (n = 34), FIGO 1988 Ib group (n = 156) and FIGO 1988 Ic group (n = 29). The others 25 cases were stage IIa (n = 16) and stage IIIa with merely positive abdominal cytology (n = 9) according to FIGO 1988 staging system.(2) The higher percentage of low-grade in FIGO 1988 Ia group than that in FIGO 2009 Ia group (P = 0.003). Compared with FIGO 2009 Ia group, the age of the patients, surgery extent, the percentage of lymph node excision and received chemotherapy and radiotherapy, there were no difference in FIGO 1988 Ia and Ib group, respectively (P > 0.05). There were 5.9% (2/34) and 6.7% (10/150) found relapse among FIGO 1988 Ia group and FIGO 1988 Ib group, and there were 2.9% (1/34) and 2.7% (4/150) for the two groups died of carcinoma. Compared with FIGO 2009 Ia group, there were not significant difference [7.5% (13/200) vs. 3.0% (6/200); P > 0.05]. The 5 years and 10 years progression-free survival (PFS) of FIGO 1988 Ia group and Ib group were (97.0 ± 3.0)%, (90.9 ± 6.5)% and (95.3 ± 2.1)%, (90.2 ± 3.6)%, respectively, in which there were not significant difference compared with that in FIGO 2009 Ia group [(96.1 ± 1.6)%, (89.6 ± 3.2)%; P > 0.05]. The 5 years and 10 years overall survival (OS) in FIGO 1988 Ia group and Ib group were 100%, (93.8 ± 6.0)% and (96.9 ± 1.8)%, (95.2 ± 2.5)%, respectively, in which there were did not significant difference with that in FIGO 2009 Ia group [(97.9 ± 1.2)%, (93.4 ± 2.8)%; P > 0.05].(3) There were not significant difference between FIGO 1988 Ic group and FIGO 2009 Ib group (P > 0.05) for the age of the patients, grade, surgery extent, lymph node excision, the percentage of received chemotherapy and radiotherapy. Between FIGO 1988 Ic group and FIGO 2009 Ib group, there were 3.4% (1/29) and 6.8% (3/44) cases found relapse, respectively. And there were 0 and 2.3% (1/44) cases died of carcinoma in the two groups, in which there were not differ much either (P > 0.05). The 5 years and 10 years PFS in FIGO 1988 Ic group were all 100%, while they were 100% and (90.9 ± 6.2)% in FIGO 2009 Ib group. The 5 years and 10 years OS in FIGO 1988 Ic group were all 100%, but were 100% and (95.0 ± 4.9)% in FIGO 2009 Ib group, in which they all did not significantly differ much (P > 0.05). (4) The patients in FIGO 2009 Ia group were younger than those in FIGO 2009 Ib group (P < 0.01). The percentage of low grade in FIGO 2009 Ia group were higher than that in FIGO 2009 Ib group (P = 0.029). The percentages of received chemotherapy and radiotherapy in FIGO 2009 Ia group were lower than that in FIGO 2009 Ib group remarkably (P < 0.01). But there were not significant difference in the uterine excision extent and the percentage of lymph node excision between the two groups (P > 0.05). There were not significantly differ in the relapse rates and the death rates between the FIGO 2009 Ia group and FIGO 2009 Ib group (P > 0.05). There were also not significant difference in PFS and OS between the two groups (P > 0.05). There were not significant difference in the prognosis between FIGO 2009 stage Ia and FIGO 1988 stage Ia and Ib. There were also not significant difference in the prognosis between FIGO 2009 stage Ia and FIGO 2009 stage Ib, which may be due to received more chemotherapy and radiotherapy in FIGO 2009 stage Ib patients.

To investigate the practical value of the International Federation of Gynecology and Obstetrics (FIGO) 2023 endometrial cancer (EC) staging system. Data on clinicopathological characteristics of patients diagnosed with EC at Tianjin Central Hospital of Gynecology Obstetrics from January 2015 to December 2017 were collected. Initial staging was performed using the FIGO 2009 system, followed by revised staging with the 2023 FIGO system. The oncological outcomes of patients under the different staging systems were analyzed. A total of 671 patients with EC were included in this study, and after applying the 2023 FIGO staging system, the staging of 119 (17.73%) patients changed, with 11 (1.64%) patients experiencing downstaging and 108 (16.10%) patients experiencing upstaging; 5-year progression-free survival (PFS) and overall survival (OS) rates changed in stage I (97.75%-98.55% and 98.79%-99.38%, respectively) and stage II (91.39%-93.16% and 95.65%-95.72%, respectively) patients, and the differences in PFS (P = 0.060 and P = 0.001, respectively) and OS (P = 0.349 and P = 0.003, respectively) between stage I and stage II patients became statistically significant. After the restaging of FIGO 2009 stage I patients, there were statistically significant differences in PFS (P = 0.002 and P = 0.024, respectively) and OS (P = 0.002 and P = 0.002, respectively) between stage IIB and IA1 and IA2 patients, and significant differences in PFS (P = 0.022) and OS (P = 0.048) were observed between stage IIC and IA1 patients. In FIGO 2023 stage IIB and IIC patients, the differences in PFS (P = 0.39 and P = 0.39, respectively) and OS (P = 0.78 and P = 0.5, respectively) were not statistically significant among the various FIGO 2009 stages. In the FIGO 2023 EC staging system, stage I and II staging criteria are more reasonable, and the addition of stage IIB and IIC helps to better evaluate patient prognosis.

Simple SummaryWe aimed to compare the prognosis of patients with advanced hepatocellular carcinoma treated with the first-line atezolizumab plus bevacizumab (AB) combination chemotherapy and the less popular locoregional treatment mainly used in East Asia, hepatic artery infusion chemotherapy (HAIC). We conducted a retrospective study with 114 patients treated with AB and 193 patients treated with HAIC and compared the overall survival (OS) and progression-free survival (PFS). Our results showed comparable OS between the two therapy groups; however, PFS was superior in patients treated with AB combination therapy. After compensating for confounding variables via propensity score matching, there was no significant difference in PFS and OS between the two groups.This study aimed to compare the prognosis and characteristics of patients with advanced hepatocellular carcinoma treated with first-line atezolizumab plus bevacizumab (AB) combination therapy and hepatic artery infusion chemotherapy (HAIC). We retrospectively assessed 193 and 114 patients treated with HAIC and AB combination therapy, respectively, between January 2018 and May 2023. The progression-free survival (PFS) of patients treated with AB combination therapy was significantly superior to that of patients treated with HAIC (p < 0.05), but there was no significant difference in overall survival (OS). After propensity score matching, our data revealed no significant differences in OS and PFS between patients who received AB combination therapy and those who received HAIC therapy (p = 0.5617 and 0.3522, respectively). In conclusion, our propensity score study reveals no significant differences in OS and PFS between patients treated with AB combination therapy and those treated with HAIC.

A multicenter, real-world analysis of primary central nervous system lymphoma in those with and without human immunodeficiency virus.

320 Background: Immune checkpoint combination therapy (ICI-combo) is the new standard of care for mRCC in first-line setting. However, pts with poor PS (≥2) were excluded from pivotal trials. Hence, the activity and safety of ICI-combo in this group of pts is still unknown. Methods: We performed a multicentre retrospective study of PS≥2 mRCC pts who received ICI-combo, either nivolumab-ipilimumab (NI) or pembrolizumab-axitinib (PA) as first-line treatment between 2017-2021. Patient’s characteristics, clinical outcomes and toxicity were retrospectively reviewed. We analysed overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and grade ≥3 treatment-related adverse events (G≥3 AEs) in pts treated with NI or PA. The association between LIPI (Lung Immune Prognostic Index) and ORR, PFS and OS was also evaluated. Results: We identified 56 mRCC pts with PS≥2 treated with ICI-combo across 13 institutions. Thirty-six and 20 pts were treated with NI and PA respectively. Median age at diagnosis was 64 (31-83) years, 38 (68%) were male, 16 (29%) had prior nephrectomy and 40 (71%) had synchronous metastatic disease at diagnosis. Respectively, 19 (34%) and 37 (66%) pts were intermediate and poor risk according to IMDC. Fifty pts (89%) were clear cell RCC, and only 4 pts had sarcomatoid features reported. At the time of analysis (median follow-up 11.1 months(mo)) 45% pts were dead. The ORR for the entire cohort was 27%; ORR was numerically higher with PA (42%) than with NI (20%) but did not reach statistical significancy (p=0.157). Median PFS (mPFS) and mOS in the entire cohort were 4.4 mo and 15.9 mo respectively. No significant differences in PFS, OS or the rate of G≥3AEs were seen between the NI and PA groups. Efficacy and toxicity outcomes are described in the table below. No significant differences in OS or PFS according to the IMDC risk score were observed (p=0.818). However, LIPI was significantly associated with OS (poor LIPI: HR=8.18; p=0.004) and PFS (Intermediate LIPI: HR=2.4; p=0.048 and poor LIPI: HR=8.59; p&lt;0.001). LIPI was predictive of response in patients treated with NI (p=0.024). Conclusions: We report the first cohort of PS≥2 mRCC pts treated with ICI-combo in first-line setting. No significant differences in ORR, PFS or OS were seen between NI and PA. LIPI was significantly associated with both OS and PFS, and was predictive of ORR in the NI group. Prospective real-world studies are needed to confirm these results.[Table: see text]

Introduction/Background*Epithelial ovarian cancer (EOC) patients undergoing splenectomy during cytoreductive surgery represent a small subgroup of patients. Splenic metastases or technical reasons due to extensive upper abdominal disease may require a...

To evaluate the performance of the second revision of the International Staging System 2 (R2ISS)1 in a real-world cohort, we applied the scoring system to patients with newly-diagnosed multiple myeloma (NDMM) in the Myeloma and Related Diseases Registry (MRDR). Our analysis establishes the validity of this risk scoring system in a real-world setting, in addition to being able to further risk-stratify the Revised International Staging System (R-ISS) group II category. The R2ISS is a recently described update to the established R-ISS for NDMM patients. In addition to β2-microglobulin, albumin, lactate dehydrogenase (LDH), del17p, and t(4;14) by fluorescence-in-situ hybridisation (FISH) included in the R-ISS, the R2ISS additionally considers gain of chromosome 1q (1q+), and adds additional weight when more than one high-risk cytogenetic abnormality is present.2 The cytogenetic abnormality t(14;16) is no longer included in the R2ISS. The impetus for this revision was poor discrimination within the intermediate risk stage (stage II) by the R-ISS, which categorises more than 50% of patients within this one group despite heterogeneous disease outcomes.3 The R2ISS stratifies patients by assigning a score value (in square brackets) to the included prognostic variables: ISS II [1], ISS III [1.5], del(17p) [1], high LDH [1], t(4;14) [1], and 1q+ [0.5]. The sum of these scores determines the risk group: I low (0), II low/intermediate (0.5–1), III intermediate/high (1.5–2.5) and IV high.3-5 A limitation of the creation of this system was its derivation from a platform that exclusively enrolled clinical-trial participants. Such participants are highly selected based on trial eligibility criteria and receive myeloma therapy that by definition deviates from current standards of care. Thus, prior to widespread adoption, there is a need to validate this risk stratification system within a non-clinical-trial 'real-world' population. To assess its real-world value, we retrospectively applied R2ISS scoring to patients in the MRDR, that prospectively collects data on NDMM patients from 56 Australian and New Zealand centres.4 All NDMM patients at each participating site are invited to join the registry, and their data are included unless they opt off, which is rare.5 Progression-free survival (PFS) was defined as the time from diagnosis until disease progression or all-cause mortality. Overall survival (OS) was defined as the time from diagnosis until death from any cause. FISH for del17p, (4;14) and 1q+ was performed at the designated central reference laboratory for each state/country on CD138+ enriched cells. The cut-off for FISH positivity differs between sites, ranging from 10% to 15% for IgH translocations and from 10% to 20% for numerical aberrations. The Kaplan–Meier method was used to calculate curves for PFS and OS, with groups compared using the log-rank test. Of the 3483 patients diagnosed from January 2012 to February 2022, complete staging data (ISS, LDH and FISH) was evaluable for 1289 (37%) patients. Disease progression and survival data were available for 1272 (36.5%) and 1275 (36.7%) patients respectively. Median follow-up was 32 months. Patient demographic and clinical characteristics are described in Table 1. R2ISS score-stratified PFS is shown in Figure 1. Median PFS in R2ISS group I was 40.2months [95% confidence interval (95% CI) 34.5–51.5 months], in group II it was 42.3 months (95% CI 36.1–50.6 months), in group III it was 24.0 months (95% CI 21.6–27.4 months), and in group IV it was 21.0 months (95% CI 14.1–25.4 months). There was a significant difference in PFS between R2ISS risk groups I versus III [hazard ratio (HR) 2.0 (95% CI 1.5–2.6), p < 0.001] and groups I versus IV [HR 2.9 (95% CI 2.0–4.1), p < 0.001], but not group I versus II [HR 1.0 (95% CI 0.8–1.4), p = 0.761]. R2ISS score-stratified OS is shown in Figure 1B. Median OS was not reached (NR) by 84 months in groups I and II (95% CI 73.4–NR months and 90.8–NR months respectively), in group III it was 51.3 months (95% CI 45.4–67.0 months), and in group IV it was 48.5 months (95% CI 41.9-NR months). There was a significant difference in OS of R2ISS risk groups I versus III [HR 2.9 (95% CI 2.0–4.2), p < 0.001] and of groups I versus IV [HR 3.5 (95% CI 2.1–5.7), p <0.001], but not of groups I versus II [HR 1.1 (95% CI 0.8–1.7), p = 0.526]. We further assessed the redistribution of R-ISS groups following R2ISS recategorisation. Of the patient cohort, 873 (67.7%) were categorised as R-ISS stage II. When recategorised by R2ISS these patients were redistributed across all four R2ISS risk groups: 0.9% (8/873) in group I, 47.8% (417/873) in group II, 48.1% (420/873) in group III, and 3.2% (28/873) in group IV, underscoring the heterogeneity of the R-ISS's stage II classification. It is worth noting that the recategorisation of patients in R-ISS group II as R2-ISS group I was due to t(14;16) not contributing to R2-ISS scoring. We analysed the outcomes of the R-ISS II risk group alone according to the R2ISS scores. R2ISS risk group II was used as a baseline comparative population due to low numbers in R2ISS risk group I. We found statistically significant differences in the outcomes of R2ISS risk group II versus III [PFS HR 1.7 [95% CI 1.4–2.1], p < 0.001; OS HR 2.1 (95% CI 1.6–2.9), p < 0.001] and of R2ISS risk group II versus IV [PFS HR 2.3 [95% CI 1.4–3.7], p = 0.002; OS HR 2.3 (95% CI 1.1–4.6), p = 0.020] in both PFS and OS (Figure 1C,D). To our knowledge, our study is the first study externally validating the R2-ISS risk stratification system with no additional published studies using this system to date. Our study has a number of strengths, including its large sample size from 56 sites across two countries. In addition, the MRDR's linkage to national death registries ensures the reliability of our survival outcome data. While a limitation of our analysis relates to the limited proportion of our real-world patients with all required staging data points, we believe the evaluable population is representative due to the broad inclusion criteria for the MRDR and the proportional representation of ISS and R-ISS staging categories within this population being consistent with those found in previous studies.2, 6 R2ISS was evaluable in 37% of patients, comparable to the D'Agostino training and validation cohorts at 2226/7072 (31.4%) and 1214/3771 (32.2%) respectively. There was no difference in PFS (p=0.61) between the evaluable and non-evaluable groups. Median OS was fractionally longer in the evaluable group (78.9 months, 95% CI 72.4–87.8 months) than the non-evaluable group (70.1 months, 95% CI 66.2–76.7 months; p = 0.009) which appears to relate to a younger median age in the former group than the latter (68.9 vs. 66.5 years respectively; p < 0.001). FISH was the most common missing factor (71.7%). This illustrates a potential limitation of this measure as a prognostic indicator for retrospective studies outside of a trial environment, and serves as a pertinent reminder to revise national and international guidelines recommending complete staging (including cytogenetic analyses) be performed at diagnosis. The greater availability of complete staging data would allow risk stratification systems such as the R2-ISS to be fully evaluated in future populations. The R2ISS was able to stratify our cohort PFS and OS into four risk groups; however, the clear distinction achieved between R2ISS groups I versus II and III versus IV was not reflected in this real-world analysis. This observation may be explained by the difference in up-front treatment approaches between our cohort and that of D'Agostino et al. (1), where the majority received either immunodulatory drugs (IMiDs) alone (training group 23%; validation group 87%) or in combination with a proteasome inhibitor (PI; training group 67%; validation group 13%), whereas the majority of our patients received either a PI alone (72.5%) or in combination with an IMiD (19.8%). The shorter length of follow-up (32 months vs 75 months in the D'Agostino cohort1) may also have been insufficient to observe a difference in survival between groups I and II. The four-risk-group system that the R2ISS proposes aids the design of future interventional trials by facilitating population dichotomisation (i.e. pairing R2ISS group I with II and group III with IV; Figure 1E,F). Our analysis of OS according to the R2ISS, where similar outcomes were experienced by groups I and II and by groups III and IV, is supportive of this. We did not see a significant difference in either OS or PFS between patients in R2ISS groups I and II, but this may reflect a lack of power in our cohort to resolve the difference of the magnitude observed by D'Agostino et al. Our analysis also concurs with the prior demonstration that patients in R2ISS groups III and IV have a particularly poor outcome with PFS and OS markedly lower when compared to the lower-risk groups, therefore representing a subset that requires novel approaches. In summary, we show that the R2ISS score effectively differentiates the R-ISS stage II category, addressing a shortfall of the R-ISS system. However, in this large real-world myeloma population, the clear distinction between R2ISS groups I versus II and III versus IV was not reproduced. Modifications to the ISS/R-ISS systems should similarly be derived and/or assessed within real-world populations in addition to, or potentially in preference to, the highly selected populations that typically comprise clinical trials. Tan Joanne L. C. Tan wrote the paper. Cameron Wellard analysed the data. Elizabeth M. Moore, Peter Mollee, Rajeev Rajagopal, Hang Quach, Simon James Harrison, McDonald Emma-Jane, P. Joy Ho, H. Miles Prince, Bradley M. Augustson, Philip Campbell, Zoe K. McQuilten and Erica M. Wood contributed substantially in the writing and editing of the draft. Andrew Spencer is the leading supervising author and has contributed in the analysis and writing of the paper. The authors thank the patients, hospitals, clinicians and research staff at participating institutions for their support of the MRDR. The Myeloma and Related Diseases Registry has received funding from the following companies: Abbvie, Amgen, Antengene, Bristol-Myers Squibb, Celgene, Gilead, Janssen, Novartis, Sanofi, & Takeda. All authors have no conflicts of interest to declare.

A total of 251 patients with epithelial ovarian cancer (EOC) treated between 2002 and 2008 was retrospectively analyzed to investigate the long-term outcomes and prognostic factors of these patients, particularly those who underwent primary debulking surgery followed by platinum-based chemotherapy. Clinicopathological parameters, including progression-free survival (PFS) and overall survival (OS), were also analyzed. The median follow-up period from the end of initial treatment to June 2010 was 58 months. The three-year PFS rate was 61.7% for International Federation of Gynecology and Obstetrics (FIGO) I-II, 19.9% for FIGO III-IV, and 33.9% for all stages. By comparison, the five-year PFS rate was 44.6% for FIGO I-II, 17.7% for FIGO III-IV, and 28.3% for all stages. The three-year OS rate was 67.9% for FIGO I-II, 41.7% for FIGO III-IV, and 50.2% for all stages. The five-year OS rate was 52.7% for FIGO I-II, 30.8% for FIGO III-IV, and 39.2% for all stages. Univariate analysis revealed that advanced FIGO stage, serum CA125, and suboptimal debulking were significant factors affecting PFS and OS. In multivariate analysis, PFS was significantly influenced by FIGO stage and suboptimal debulking. However, OS was significantly influenced by advanced FIGO stage only. Our study confirms the efficacy of surgery followed by platinum-based chemotherapy for EOC. FIGO stage is considered as one of the most reliable predictors of the prognosis of patients with EOC.

The aim of this study was to evaluate whether body weight changes in patients undergoing chemotherapy for epithelial ovarian cancer (EOC) influence progression-free survival (PFS) and overall survival (OS). An analysis of 190 patients diagnosed with ovarian cancer after first-line chemotherapy was conducted. Changes in body weight were assessed by comparing measurements at baseline to those of the third and sixth cycles of chemotherapy. PFS and OS were calculated with the Kaplan-Meier method and multivariate Cox model. Significant reduction in body weight in advanced EOC was observed with no changes in early EOC. Significant differences in PFS were observed in advanced EOC patients that lost more than 5% of their body weight (6months), maintained weight (13months), or gained more than 5% of their body weight (15months). Similarly, significant differences in OS were noted in advanced EOC at the following time points: 24.3, 42.4, and 66.2months. No effect was reported for early EOC patients. The multivariate Cox analysis showed significant body weight changes from the first to the sixth chemotherapy cycle for PFS (HR=0.97; 95% CI 0.95-0.99) and OS (HR=0.94; 95% CI 0.91-0.97) as well as from the first to the third chemotherapy cycle for OS (HR=0.93; 95% CI 0.88-0.98). Body weight changes can be recognized as a prognostic factor for PFS and OS in advanced EOC patients undergoing chemotherapy. Weight loss is associated with poorer survival while weight gain improved outcomes.

Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

BackgroundThe majority of death-related ovarian cancer is epithelial ovarian cancer (EOC). Regarding the Federation of Gynecology and Obstetrics (FIGO) stage IV EOC, the 5-year overall survival (OS) has not changed in last decades. Platelet (PLT) count and CA125 level are both prognostic markers that related to inflammation and immune evasion in EOC. This study intended to assess the prognostic value of pretreatment PLT count and CA125 level in FIGO stage IV EOC.MethodsThe study included 108 patients diagnosed with FIGO stage IV EOC and treated with surgery and/or chemotherapy between January 1995 and December 2016. The PLT counts and CA125 levels of the patients before any treatment were analysed with clinical and pathological parameters, OS and progression-free survival (PFS). The survival of different groups was analyzed using the Kaplan-Meier method. The PLT-CA125 scores (0, 1, and 2) were defined basing on the presence of thrombocytosis (PLT count > 400,000/μL), an elevated CA125 level (CA125 > 1200 U/mL), or both. The prognostic value of PLT-CA125 was assessed with a Cox regression model.ResultsMedian OS, but not median PFS, was significantly decreased in patients with thrombocytosis or elevated CA125 levels when compared with the others (p = 0.011 & p = 0.004). The median OS was significantly decreased in patients with a PLT-CA125 score of 2 [37.8 months; 95% confidence interval (CI) 20.6–54.9] compared with patients with a PLT-CA125 score of 0 (70.0 moths, 95% CI 38.0–101.9, p < 0.001). The median PFS was also significantly decreased in patients with a PLT-CA125 score of 2 (19.6 months; 95% CI 13.0–26.3) compared with patients with a PLT-CA125 score of 0 (32.0 months; 95% CI 23.3–40.7, p = 0.011). Furthermore, multivariate analysis identified both PLT-CA125 scores of 2 and 1 as independent poor prognostic factors for OS (p = 0.004 & p < 0.001) and PFS (p = 0.033 & p = 0.017) compared with a PLT-CA125 score of 0.ConclusionsThe pretreatment PLT-CA125 score can be a reliable marker with high accessibility for stratifying prognosis in patients with FIGO stage IV EOC.

BackgroundThe aim of the study was to analyze the overall survival (OS) and progression free survival (PFS) of patients with high grade and advanced stage epithelial ovarian cancer (EOC) with at least 60 months of follow-up treated in a single gynecologic oncology institute. We compared primary debulking surgery (PDS) versus neoadjuvant chemotherapy plus interval debulking surgery (NACT + IDS) stratifying data based on residual disease with the intent to identify the rationale for therapeutic option decision and the role of laparoscopic evaluation of resectability for that intention.Patients and methodsThis is observational retrospective study on consecutive patients with diagnosis of high grade and International Federation of Gynecology and Obstetrics (FIGO) stage III/IV EOC referred to our center between January 2008 and May 2012. We selected only patients with a follow-up of at least 60 months. Primary endpoint was to compare PDS versus NACT + IDS in term of progression free survival (PFS) and overall survival (OS). Secondary endpoints were PFS and OS stratifying data according to residual disease after surgery in patients receiving PDS versus NACT + IDS. Finally, through Cox hazards models, we tested the prognostic value of different variables (patient age at diagnosis, residual disease after debulking, American Society of Anesthesiologists (ASA) stage, number of adjuvant-chemotherapy cycles) for predicting OS.ResultsA total number of 157 patients were included in data analysis. Comparing PDS arm (108 patients) and NACT + IDS arm (49 patients) we found no significant differences in term of OS (41.3 versus 34.5 months, respectively) and PFS (17.3 versus 18.3 months, respectively). According to residual disease we found no significant differences in term of OS between NACT + IDS patients with residual disease = 0 and PDS patients with residual disease = 0 or residual disease = 1, as well as no significant differences in PFS were found comparing NACT + IDS patients with residual disease = 0 and PDS patients with residual disease = 0; contrarily, median PFS resulted significantly lower in PDS patients receiving optimal debulking (residual disease = 1) in comparison to NACT + IDS patients receiving complete debulking (residual disease = 0). PDS arm was affected by a significant higher rate of severe post-operative complications (grade 3 and 4). Diagnostic laparoscopy before surgery was significantly associated with complete debulking.ConclusionsWe confirm previous findings concerning the non-superiority of NACT + IDS compared to PDS for the treatment of EOC, even if NACT + IDS treatment was associated with significant lower rate of post-operative complications. On the other hand, selecting patients for NACT + IDS, based on laparoscopic evaluation of resectabilty prolongs the PFS and does not worse the OS compared to the patients not completely debulked with PDS.

Objective: To investigate the clinical features and survival of multiple myeloma-associated amyloidosis patients. Methods: Twenty three multiple myeloma-associated amyloidosis patients were retrospectively analyzed from January 2009 to December 2016. Results: The overall response rate(ORR)was 65.2% and the remission rate (sCR+ CR) was 21.7%. The median progression-free survival(PFS) was fourteen months(1-63), and the median overall survival(OS)was fifteen months(3-63). The early death rate (death rate within one year)was 33.3%. The median OS of patients(n=9)with the performance status(PS) score >2 was seven months(1-15), and the median OS of patients(n=14)with the PS score ≤2 was thirty months(10-63). There was a statistically significant difference in OS(P<0.05); the median PFS and OS of the patients (n=15) who responded to inductive treatment were seventeen months(2-63) and twenty four months (4-63)respectively, and the median PFS and OS of the patients (n=8)who did not respond to inductive treatment were three months(1-8) and eleven months (3-15) respectively. There was a statistically significant difference in PFS and OS(P<0.05). There was a statistically significant difference in PFS and OS between patients treated with remission (n=5)and those who did not(n=18) (P<0.05). Conclusions: The multiple myeloma-associated amyloidosis patients had a high early death rate and short survival time. Early identification and effective treatment are the preconditions for improving the poor prognosis.

To investigate the role of perioperative chemoradiotherapy (CRT) in the treatment of locally advanced thoracic esophageal squamous cell carcinoma (ESCC). Using preoperative computed tomography (CT)-based staging criteria, 238 patients with ESCC (stage II-III) were enrolled in this prospective study between January 1997 and June 2004. With informed consent, patients were randomized into 3 groups: preoperative CRT (80 cases), postoperative CRT (78 cases) and surgery alone (S) (80 cases). The 1-, 3-, 5- and 10-year survival were followed up. Progression-free survival (PFS) was chosen as the primary endpoint by treatment arm measured from study entry until documented progression of disease or death from any cause. The secondary endpoint was overall survival (OS) determined as the time (in months) between the date of therapy and the date of death. Other objectives were surgical and adjuvant therapy complications. With median follow-up of 45 mo for all the enrolled patients, significant differences in the 1-, 3-, 5-, 10-year OS (91.3%, 63.5%, 43.5%, 24.5% vs 91%, 62.8%, 42.3%, 24.4% vs 87.5%, 51.3%, 33.8%, 12.5%, P = 0.0176) and PFS (89.3%, 61.3%, 37.5%, 18.1% vs 89.1%, 61.1%, 37.2%, 17.8% vs 84.5%, 49.3%, 25.9%, 6.2%, P = 0.0151) were detected among the 3 arms. There were no significant differences in OS and PFS between the preoperative CRT and postoperative CRT arm (P > 0.05). For the patients who had radical resection, significant differences in median PFS (48 mo vs 61 mo vs 39.5 mo, P = 0.0331) and median OS (56.5 mo vs 72 mo vs 41.5 mo, P = 0.0153) were detected among the 3 arms, but there were no significant differences in OS and PFS between the preoperative CRT and postoperative CRT arm (P > 0.05). The local recurrence rates in the preoperative CRT, postoperative CRT group and S group were 11.3%, 14.1% and 35%, respectively (P < 0.05). No significant differences were detected among the 3 groups when comparing complications but tended to be in favor of the postoperative CRT and S groups (P > 0.05). Toxicities of CRT in the preoperative or postoperative CRT arms were mostly moderate, and could be quickly alleviated by adequate therapy. Rational application of preoperative or postoperative CRT can provide a benefit in PFS and OS in patients with locally advanced ESCC.

Progression-free survival: Starting point or endpoint in advanced HCC trial design?