Preoperative Radiation Therapy Followed by Reexcision May Improve Local Control and Progression-Free Survival in Unplanned Excisions of Soft Tissue Sarcomas of the Extremity and Chest-Wall

Background. The management for unplanned excision (UE) of soft tissue sarcomas (STS) has not been established. In this study, we compare outcomes of UE versus planned excision (PE) and determine an optimal treatment for UE in STS.Methods. From 2000 to 2014 a review was performed on all patients treated with localized STS. Clinical outcomes including local recurrence-free survival (LRFS), progression-free survival (PFS), and overall survival (OS) were evaluated using the Kaplan-Meier estimate. Univariate (UVA) and multivariate (MVA) analyses were performed to determine prognostic variables. For MVA, Cox proportional hazards model was used.Results. 245 patients were included in the analysis. 14% underwent UE. Median follow-up was 2.8 years. The LR rate was 8.6%. The LR rate in UE was 35% versus 4.2% in PE patients (p<0.0001). 2-year PFS in UE versus PE patients was 4.2 years and 9.3 years, respectively (p=0.08). Preoperative radiation (RT) (p=0.01) and use of any RT for UE (p=0.003) led to improved PFS. On MVA, preoperative RT (p=0.04) and performance status (p=0.01) led to improved PFS.Conclusions. UEs led to decreased LC and PFS versus PE in patients with STS. The use of preoperative RT followed by reexcision improved LC and PFS in patients who had UE of their STS.

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Association of morphologic response with progression free survival in patients with metastatic colorectal cancer treated with bevacizumab-based chemotherapy: HGCSG0802.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.743 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 743-743

Author(s):

Satoshi Yuki ◽

Hiroshi Nakatsumi ◽

Hideyuki Hayashi ◽

Hiraku Fukushima ◽

Takashi Kato ◽

...

Keyword(s):

Proportional Hazards ◽

Proportional Hazards Model ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Rank Test ◽

First Line ◽

Free Survival ◽

Contrast Enhanced Ct ◽

Morphologic Response

743 Background: It was reported that an optimal morphologic response to preoperative chemotherapy was associated with better overall survival (OS) in patients (pts) with colorectal liver metastases (CLM). We investigated association of morphologic response with progression free survival (PFS) in pts with unresectable CLM from HGCSG0802 observational cohort study in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy. Methods: The objective of HGCSG0802 was to evaluate PFS, OS, time to treatment failure (TTF), response rate (RR), safety, etc. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. Pts with CLM underwent contrast-enhanced CT at the start and every 8-weeks of BV-based chemotherapy. In this analysis, three blinded, independent radiologists evaluated images for morphologic response, based on metastases changing from heterogeneous masses with ill-defined margins into homogeneous hypoattenuating lesions with sharp borders. Association of morphologic response and pts characteristics, RR, and PFS were evaluated. PFS was analyzed with Kaplan-Meier method, log-rank test, and Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 73 pts with CLM were evaluable for morphologic criteria. Eighteen pts (24.7%) had optimal morphologic response (OR), 31 (42.5%) had incomplete (IR), and 24 (32.9%) had no response (NR). The pts characteristics between those with OR, IR and NR were generally balanced. The median TTF was 7.2 months in NR versus 7.2 months in IR versus 6.8 months in OR (HR (OR/NR) = 0.91, HR (OR/IR) = 0.90; p = 0.93). RR was 77.8% in OR versus 64.5% in IR and 58.3% in NR (p = 0.528). The median PFS was 8.3 months in NR versus 8.5 months in IR versus 9.1 months in OR (HR (OR/NR) = 0.72, HR (OR/IR) = 1.04; p = 0.420). Conclusions: In this analysis, morphologic response might not be a prognostic marker in first-line BV-based chemotherapy in pts with CLM.

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Analysis of the GERCOR index in KRAS Exon2 WT patients with mCRC treated with salvage-line cetuximab-based chemotherapy: HGCSG0901.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.781 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 781-781

Author(s):

Ayumu Hosokawa ◽

Satoshi Yuki ◽

Hiroshi Nakatsumi ◽

Kazuteru Hatanaka ◽

Yasushi Tsuji ◽

...

Keyword(s):

Multivariate Analysis ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Performance Status ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Rank Test ◽

Prognostic Impact ◽

Significant Difference

781 Background: The GERCOR index (GI) based on performance status and serum LDH was reported to be useful to predict survival for patients with previously untreated mCRC. However, in the salvage setting, the validity of the GI has not been reported in patients treated with cetuximab (Cmab)-based chemotherapy. Methods: 269 patients with mCRC treated with Cmab contained chemotherapy were retrospectively registered from 27 centers in Japan. This analysis was included in the KRAS Exon2 wild type patients who were refractory to or intolerant of 5-FU / irinotecan/ oxaliplatin and were never administered anti-EGFR-antibody. Univariate and multivariate analysis for overall survival (OS) were performed using patient characteristics. Survival analyses were performed with the Kaplan-Meier method, log-rank test and the Cox proportional hazards model. The analysis was also designed to determine whether the GERCOR index could be extended to progression-free survival (PFS). Results: All data were available for prognostic categorization in 132 patients. Median OS and PFS were 9.8 and 4.3 months. The distribution and median OS / PFS for GI were as follows: low risk (L)(n = 28; 17.9/3.8 months), intermediate risk (I)(n = 52; 12.2/5.0 months), and high risk (H)(n = 52; 7.5/4.1 months). For OS, there was significant difference between L and H (p < 0.001) and between I and H (p < 0.001), but not between L and I (p = 0.076). For PFS, there was significant difference between I and H (p = 0.017), but not between L and I (p = 0.407), and between L and H (p = 0.222). In the Cox multivariate analysis, GI showed an independent prognostic impact (L vs. I ; HR 2.195, p=0.003 / L vs. H ; HR 4.028, p<0.001), but not predictive impact (L vs. I ; HR 0.987, p=0.958 / L vs. H ; HR 1.314, p=0.268). Conclusions: In this analysis, GI might be a prognostic factor in salvage treatment with Cmab-based chemotherapy.

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Validation of Neutrophil Count as An Algorithm-Based Predictive Factor of Progression-Free Survival in Patients with Metastatic Soft Tissue Sarcomas Treated with Trabectedin

Cancers ◽

10.3390/cancers11030432 ◽

2019 ◽

Vol 11 (3) ◽

pp. 432 ◽

Cited By ~ 1

Author(s):

Alexandre de Nonneville ◽

Dominique Barbolosi ◽

Maeva Andriantsoa ◽

Raouf El-Cheikh ◽

Florence Duffaud ◽

...

Keyword(s):

Soft Tissue ◽

Neutrophil Count ◽

Predictive Factor ◽

Lung Metastases ◽

Performance Status ◽

Survival Rates ◽

Soft Tissue Sarcomas ◽

Progression Free Survival ◽

Tumor Grade ◽

Free Survival

Introduction: Based on a mathematical model of trabectedin-induced neutropenia, we assessed the predictive value of absolute neutrophil count (ANC) on progression-free survival (PFS) in an independent validation cohort of patients treated with trabectedin. Methods: We collected data from 87 patients in two expert centers who received at least two cycles of trabectedin for soft tissue sarcomas (STS) treatment. Correlations between ANC, patients’ characteristics, and survival were assessed, and a multivariate model including tumor grade, performance status, ANC, and hemoglobin level was developed. Results: Therapeutic ANC ≥ 7.5 G/L level was associated with shorter PFS: 3.22 months (95% confidence interval (CI), 1.57–4.87) in patients with ANC ≥ 7.5 G/L vs. 5.78 months (95% CI, 3.95–7.61) in patients with ANC < 7.5 G/L (p = 0.009). Age, primary localization, lung metastases, dose reduction, hemoglobin, and albumin rates were also associated with PFS. In multivariate analysis, ANC ≥ 7.5 G/L was independently associated with poor PFS and overall survival. Conclusion: We validated increased pre-therapeutic ANC as a predictive factor of short PFS in patients starting trabectedin for STS. ANC appears to have an impact on survival rates and may be used as a decision-making tool for personalizing second-line strategies in patients with metastatic STS.

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Updated overall survival (OS) results from the phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2- advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.1001 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 1001-1001

Author(s):

Dennis J. Slamon ◽

Patrick Neven ◽

Stephen K. L. Chia ◽

Guy Heinrich Maria Jerusalem ◽

Michelino De Laurentiis ◽

...

Keyword(s):

Proportional Hazards ◽

Proportional Hazards Model ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Phase Iii ◽

Term Survival ◽

Free Survival ◽

Hazards Model

1001 Background: The Phase III MONALEESA-3 trial (NCT02422615) previously demonstrated a statistically significant improvement in OS with RIB, a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), plus FUL compared with placebo (PBO) plus FUL as first-line (1L) or second-line (2L) treatment in postmenopausal pts with HR+/HER2− ABC (median, not reached vs 40.0 mo; hazard ratio [HR], 0.72; 95% CI, 0.57-0.92, P =.00455). This analysis was final per the protocol; following the unblinding of the study, pts still on study treatment in the PBO arm were allowed to cross over to the RIB arm. We report an exploratory analysis of OS after an additional median 16.9 mo of follow-up, allowing for further characterization of long-term survival benefits of RIB. Methods: Postmenopausal pts with HR+/HER2− ABC were randomized 2:1 to receive RIB + FUL or PBO + FUL in 1L and 2L settings. Updated OS was evaluated by Cox proportional hazards model and summarized using Kaplan-Meier methods. Additional postprogression endpoints such as progression-free survival 2 (PFS2), time to chemotherapy (CT), and CT-free survival were also evaluated and summarized. Results: At the data cutoff (Oct 30, 2020), the median follow-up was 56.3 mo (min, 52.7 mo) and 68 (14.0%) and 21 (8.7%) patients were still on treatment in the RIB vs PBO arms, respectively. With this extended follow-up, RIB + FUL continued to demonstrate an OS benefit vs PBO + FUL (median, 53.7 vs 41.5 mo; HR, 0.73; 95% CI, 0.59-0.90). RIB + FUL had prolonged OS vs PBO + FUL in the 1L (median, not reached vs 51.8 mo; HR, 0.64; 95% CI, 0.46-0.88) and 2L subgroups (median, 39.7 vs 33.7 mo; HR, 0.78; 95% CI, 0.59-1.04). Subgroup analyses also showed a consistent OS benefit compared with the intent-to-treat (ITT) population for most subgroups. PFS2, time to CT, and CT-free survival for the ITT population favored RIB + FUL (Table). Among pts who discontinued study treatment, 81.9% and 86.4% received a next-line subsequent antineoplastic therapy, while 14.0% and 30.0% received a CDK4/6i as any subsequent line in the RIB vs PBO arms, respectively. No new safety signals were observed. Conclusions: The previously demonstrated robust and clinically meaningful OS benefit with RIB + FUL compared with PBO + FUL was maintained after almost 5 years of follow-up in postmenopausal pts with HR+/HER2− ABC. The OS benefit of RIB was observed in the 1L and 2L subgroups, which further supports the use of RIB in these populations. The results also demonstrated a significant delay in the use of subsequent CT with RIB vs PBO. Clinical trial information: NCT02422615 .[Table: see text]

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Arthralgia in patients with ovarian cancer treated with bevacizumab and chemotherapy

International Journal of Gynecological Cancer ◽

10.1136/ijgc-2020-001540 ◽

2020 ◽

Vol 31 (1) ◽

pp. 110-113

Author(s):

Jole Ventriglia ◽

Immacolata Paciolla ◽

Carmela Pisano ◽

Rosa Tambaro ◽

Sabrina Chiara Cecere ◽

...

Keyword(s):

Ovarian Cancer ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Residual Disease ◽

Advanced Ovarian Cancer ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Free Survival ◽

Primary Surgery

BackgroundChemotherapy with carboplatin, paclitaxel, and bevacizumab is the standard therapy for patients with advanced stage ovarian cancer wild-type BRCA after primary surgery. The most frequent side effects of bevacizumab in this setting are hypertension, thrombosis, hemorrhage, and proteinuria, while arthralgia has been poorly described.ObjectiveTo examine the incidence, duration, and reversibility of arthralgia.Patients and methodsA retrospective analysis was performed to describe the occurrence and outcome of arthralgia in 114 patients with advanced ovarian cancer, given first-line treatment with a combination of carboplatin, paclitaxel, and bevacizumab. Statistical analysis was performed to investigate a possible prognostic role of arthralgia, with progression-free survival as endpoint.Results47 of 114 patients (41%) developed arthralgia during therapy. All patients had grade 1 or grade 2 arthralgia. Toxicity persisted after the end of bevacizumab in 17/47 patients (36%). Median progression-free survival for patients without arthralgia was 18 months (95% CI 14 to 24) compared with 29 months (95% CI 21 to not reached) for patients experiencing arthralgia (p=0.03). In order to avoid possible biases related to treatment duration, a multivariable Cox proportional hazards model including toxicity as a time dependent variable and age, stage, and residual disease after primary surgery was performed. In this model no variable showed a statistically significant association with progression-free survival.ConclusionA high incidence of arthralgia (41%) was found and although rogression-free survival was worse for those patients who developed arthralgia, this was not maintained on multivariate analysis. Guidelines for treatment of this adverse event are needed.

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The real-life outcome of pazopanib in patients with advanced soft tissue sarcoma: A retrospective cross-sectional study of a Turkish cohort

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155220904138 ◽

2020 ◽

Vol 26 (7) ◽

pp. 1657-1666

Author(s):

Mustafa Karaağaç ◽

Yasin Sezgin ◽

Melek Karakurt Eryılmaz ◽

Murat Araz ◽

Muhammet Ali Kaplan ◽

...

Keyword(s):

Overall Survival ◽

Soft Tissue ◽

Soft Tissue Sarcoma ◽

Performance Status ◽

Soft Tissue Sarcomas ◽

Progression Free Survival ◽

First Line ◽

Advanced Soft Tissue Sarcoma ◽

Free Survival ◽

Common Grade

Introduction Soft tissue sarcomas are a heterogeneous and rare group of cancers with a short median overall survival despite the chemotherapy. Pazopanib has approval for the treatment of advanced soft tissue sarcoma. We aimed to investigate the clinical outcomes of Turkish patients with advanced soft tissue sarcoma who received pazopanib. Patients and methods This was a retrospective study. The inclusion criteria were: ≥18 years of age, having histologically proven advanced soft tissue sarcoma and receiving pazopanib at least one day. Results A total of 79 patients were assessed in this study. The median age was 49.6 years. The average dose intensity of pazopanib was 767 mg (400–800). The median duration of pazopanib treatment was 6.11 months. Fourteen patients (17.7%) used pazopanib at first line for advanced soft tissue sarcomas. The most common cause of discontinuation of pazopanib was the progression of the disease (89.6%). Pazopanib was well tolerated. The most common grade ≥3 side effect was anemia. The most common grade ≤2 side effects were anemia and hyperbilirubinemia. The median progression-free survival, overall survival, and follow-up were 3.97 months, 11.40 months, and 32.72 months, respectively. Female gender, good performance status, and the presence of pazopanib-induced hypothyroidism were associated with longer progression-free survival. Also, good performance status and being a responder to first-line treatment were associated with longer overall survival. Conclusions We showed that pazopanib was well tolerated and had clinical benefit in patients with advanced soft tissue sarcoma in a Turkish cohort. This is the first study that suggests pazopanib-induced hypothyroidism may act as a predictive marker for better outcomes in patients with advanced soft tissue sarcoma.

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Treatment of metastatic disease with immune checkpoint inhibitors nivolumab and pembrolizumab: Effect of performance status on clinical outcomes.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18689 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18689-e18689

Author(s):

Leah Wells ◽

Michael Cerniglia ◽

Audrey C. Jost ◽

Gregory Joseph Britt

Keyword(s):

Disease Control ◽

Proportional Hazards Model ◽

Checkpoint Inhibitors ◽

Performance Status ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Rank Test ◽

Time To Death ◽

Significant Difference ◽

Line Of Therapy

e18689 Background: While guidelines exist for appropriate use of chemotherapy in the metastatic setting based on performance status, such recommendations are less readily available for immune checkpoint inhibitors (ICIs). We sought to determine if there is a relationship between Eastern Cooperative Oncology Group (ECOG) performance status and outcomes on immunotherapy in patients treated for metastatic disease at our community-based oncology practice. Methods: 253 patients were identified as receiving nivolumab or pembrolizumab for stage IV malignancy at Cancer Centers of Colorado-SCL Health, between June 2018 and November 2020. Patients initiated on therapy after May 2020 were excluded from analysis, due to insufficient (less than 6 months) follow-up time. The remaining 183 patients were included in a retrospective cohort study comparing patients with ECOG 0, ECOG 1, and ECOG 2-4. Sex, age, type of cancer, and line of therapy were collected. Time on therapy was also calculated. Best response to therapy was determined (disease control or progressive disease). These baseline factors and outcomes were compared using ANOVA for numeric variables and chi-square tests of association for categorical variables. Time from initiation of ICI to death or hospice was also investigated and compared using a log-rank test. In addition, a multivariate Cox proportional hazards model was developed for the outcome, time to death/hospice, versus the predictors ECOG status, age, gender, and line of therapy. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated. Results: Of the 183 patients included in analysis, 31.7% had an ECOG of 0, 48.6% an ECOG of 1, and 19.7% an ECOG of 2-4. Non-small cell lung cancer and melanoma represented the majority of patients in each group. Gender and line of therapy did not differ between groups. There was a significant difference in age (p = 0.02) with mean age 62, 66, and 70 in ECOG 0,1, and 2-4, respectively. 54.6% of patients remained on therapy for at least 6 months (182 days), and there was no significant difference between groups in ability to complete 6 months of therapy (p = 0.32). For ECOG 0, 1, and 2-4, disease control was achieved in 67.2%, 59.6 %, and 41.7%, respectively (p = 0.048). Analysis of time to death/hospice with a log rank test and Kaplan Meier plot showed a significant difference between groups (p < 0.001). A multivariate Cox proportional hazards model revealed that patients with ECOG 0 had significantly longer time to death/hospice compared to patients in both other groups, after controlling for age, gender, and line of therapy (ECOG 1 vs. 0: HR 2.5, CI 1.27-4.9; ECOG 2-4 vs. 0: HR 2.83, CI 1.31-6.13). Conclusions: In this single institution retrospective study of patients receiving nivolumab or pembrolizumab for metastatic cancer, ECOG 0 was associated with disease control and increased time before death or transition to hospice.

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27 Can Sarcopenia be Used to Estimate Outcomes in Elderly Patients Treated with Chemoradiotherapy for Bladder Cancer?

Age and Ageing ◽

10.1093/ageing/afab029.06 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i7-i11

Author(s):

M Corden

Keyword(s):

Skeletal Muscle ◽

Bladder Cancer ◽

Proportional Hazards Model ◽

Performance Status ◽

Survival Function ◽

Age Distribution ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

International Consensus ◽

Skeletal Muscle Index

Abstract Introduction Ageing is a risk factor for bladder cancer, with a median age at diagnosis of 71 years. In addition, sarcopenia shows promise as a prognostic biomarker for bladder cancer. This study evaluates sarcopenia as a predictor of overall survival (OS) for older patients treated with chemoradiotherapy for bladder cancer. Methods 185 bladder cancer patients treated (from 2010–2017) with chemoradiotherapy were available for analysis. Pre-therapeutic computed tomography scans were identified and single slices at the L3 level were identified. Machine learning software was used to segment skeletal muscle and obtain its cross-sectional area. This was normalised against height squared to calculate a skeletal muscle index for each patient. Sarcopenia was defined using international consensus definitions (<39 cm2/m2 in females and < 55 cm2/m2 in males). Differences in survival function between patients ≤75 and > 75 years were visualised using Kaplan–Meier curves. Age distribution between sarcopenic and non-sarcopenic patients was also explored. Finally, a multivariable Cox proportional hazards model was conducted to investigate interactions between sarcopenia and increased age with respect to OS. Results Of 185 patients, 114 (61.6%) were sarcopenic and 71 (38.4%) were non-sarcopenic; 101 (54.6%) and 84 (45.4%) patients were ≤ 75 and > 75 years old respectively. No differences in OS were observed between the two age groups (p = 0.50). There was no interaction between sarcopenia and age as a continuous variable was observed with respect to OS (p = 0.682); however, when age was categorised an interaction was seen (p = 0.058). Nevertheless, after adjusting for performance status, T-stage, hydronephrosis, albumin, haemoglobin, neutrophil and lymphocyte counts, the interactions between age and sarcopenia were no longer observed (age continuous, p = 0.474; age categorized, p = 0.765). Conclusions Patients with bladder cancer over 75 years of age have a modest increase in probability of developing sarcopenia but this does not impact on OS.

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Association of Surgical Resection, Disability, and Survival in Patients with Glioblastoma

Journal of Neurological Surgery Part A Central European Neurosurgery ◽

10.1055/s-0039-1685170 ◽

2019 ◽

Vol 80 (04) ◽

pp. 262-268 ◽

Cited By ~ 3

Author(s):

Yahya Ahmadipour ◽

Monika Kaur ◽

Daniela Pierscianek ◽

Oliver Gembruch ◽

Marvin Darkwah Oppong ◽

...

Keyword(s):

Proportional Hazards ◽

Proportional Hazards Model ◽

Karnofsky Performance Status ◽

Performance Status ◽

Extent Of Resection ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Hazards Model ◽

Surgical Modality ◽

Supratotal Resection

Objective Extent of resection (EOR) and Karnofsky Performance Status (KPS) are at odds in glioblastoma (GBM) surgery, that is, the anticipated postoperative disability limits the EOR. This study analyzes the correlation of different surgical modalities with the resulting physical status and survival of patients with GBM. Methods A total of 565 patients with primary GBM were operated on in a single institution between 2006 and 2014. Possible surgical modalities comprised supratotal resection (SLR), gross total resection (GTR; ≥ 95% by volume), tumor debulking (TDB; ≤ 95% by volume), and stereotactic biopsy (SB). Pre- and postoperative KPS before and up to 4 weeks after surgery as well as overall survival (OS) rate were determined retrospectively. Hazard ratio (HR) and 95% confidence intervals were calculated using a Cox proportional hazards model. Results Median postoperative KPS was ≥ 70, irrespective of surgical modality. Mean OS was 12.5 months. Multivariate analysis revealed age ≥ 70 years (HR: 1.93), preoperative KPS < 70 (HR: 2.15), and unmethylation in MGMT promoter (HR: 1.27) as independent factors for worse OS. Regarding surgical modality, SB was associated with the worst survival (HR: 2.3) followed by TDB (HR: 1.36). SLR was inferior to GTR (HR: 1.27). Conclusion Higher EOR in patients with GBM does not seem inevitably correlated with increasing functional impairment, but better survival, provided there is a balanced preoperative indication. Nevertheless, SLR does not seem to be superior to GTR. Whenever possible, maximal safe resection should be considered in patients with GBM, even if an EOR ≥ 95% is not possible.

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Metronomic continuous oral cyclophosphamide as second and further line in soft-tissue sarcomas (STS) of the adult.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.10572 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 10572-10572

Author(s):

Alessandro Comandone ◽

Antonella Boglione ◽

Elena Giubellino ◽

Paola Bergnolo ◽

Giancarlo Gino ◽

...

Keyword(s):

Soft Tissue ◽

Locally Advanced ◽

Soft Tissue Sarcomas ◽

Progression Free Survival ◽

Oral Cyclophosphamide ◽

Second Line ◽

Good Tolerability ◽

Free Survival ◽

Heavily Pretreated ◽

Third Line

10572 Background: In STS third line treatment is poorly defined. However many patients (pts), after aggressive therapy as first and second line progress in their disease ask to be treated. Oral cyclophosphamide (CPM) was already used in breast cancer, prostate cancer and in elderly pts with STS with favourable results. Aim of our study was to define the feasibility, tolerability and activity of oral CPM as third line and further line chemotherapy Methods: 45 pts (19 M; 26 F) with advanced or metastatic STS heavily pretreated were included. Oral CPM was given daily at total dose of 50 mg/day without interruption excepted for toxicity or progressive disease Results: Median age was 60 (32-81), histological subtypes were: leiomyosarcoma 12, liposarcoma 10, condrosarcoma 5, sinovialsarcoma 4, sarcoma NOS 4, other 10. Primary sites were: extremities 21, retroperitoneum 19, trunk 5. 41 pts were metastatic, 4 locally advanced. 41 pts were pretreated with chemotheraphy (15 were in II line, 17 in III line, 7 in IV line, 2 in V line). Median PS (ECOG) was 2 . Median duration of theraphy was 4 months (1-38). Progression free survival (PFS) ranged from 0 to 42+ months (median 4 months). Treatment was well tolerated, we registred only one episode of leucopenia G2 and one of asthenia G2. No complete responses were seen. Only 3 minimal responses and 18 stable disease were seen. Conclusions: Oral CPM showed a mild activity and good tolerability in advanced soft tissue and metastatic STS. It could be an appropriate solution as second line and further therapy and in unfit or elderly pts.

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