Analysis of the relationship between different prognosis factors in patients with advanced colon cancer and progression-free survival.

e15518 Background: Colon tumors are a heterogeneous group of disease. As a result of the accumulation of different genetic and epigenetic alterations, the mutation of the RAS, BRAF oncogene and microsatellite instability stands out. A new line of research are immunological and inflammatory factors, the infiltrating lymphocytes of the tumor stroma (TILs) and the neutrophil to lymphocyte radio (NLR) have been studied by our work team. We understood could that these factors were associated with the survival rate in our patients. The main objective of this reseach is to determine the relationship between NLR and progression-free survival (PFS) in patients with advanced colon cancer. Secondary objective is to determine the relationship between the location of the primary tumor, RAS status, TILs, and PFS. in the same group of patients. Methods: A total of 93 medical records of patients with advanced colon cancer was analyzed. Those pts who had recieved first-line chemotherapy treatment with a FOLFOX scheme plus a monoclonal antibody were included. All patients had to have a minimum follow-up of 12 months. Regarding NLR, the patients were classified into two groups: high ( = > 4) and low ( < 4). Four TILs cut-off points were determined: > 40% intense; between 11-40% moderate, 1-10% mild, and 0% absent, which were group into two categories: intense and moderate; slight and absent. Localization was divided into left and right, and KRAS status was divided into mutated and wild-type (WT). PFS was calculated using the Kaplan-Meier test. Results: The median PFS of the general population was 8.74 (7.39-11.07) months. The median PFS was 9.86 (7.82-13.41) vs 5.09 (4.43-10.84) months for low and high NLR respectively, with statistical significance (p: 0.01). When the percentage of patients without progression after one year of treatment was analyzed, the difference was 45% vs 14% in favor of NLR < 4 on ≥4, this difference was also statistically significant (p: 0.02). PFS in relation to TILs after one year of follow up was 33% (8.61 months) for moderate-intense infiltrate vs 30% of mild-absent (7.10 months). PFS was 9.79 months for KRAS WT pts vs 7.82 months for mutated KRAS. In terms of location, PFS was 9.79 months for the left colon vs 8.28 months for the right colon. These factors did not have a statistically significant difference. Conclusions: The results of the study show how NLR < 4 is a prognostic factor with a positive impact on PFS. It should be noted that the median survival rates were numerically higher in moderate-intense vs mild-absent TILs, also in KRAS WT vs mutated and in left vs right location. It should also be noted that the possibly there was not a statistically significant difference between them due to the limited number of patients per what we will continue working on in the recruitment and analysis of these patients.

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Cetuximab versus bevacizumab following prior FOLFOXIRI and bevacizumab in postmenopausal women with advanced KRAS and BRAF wild-type colorectal cancer: a retrospective study

BMC Cancer ◽

10.1186/s12885-020-07770-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Chunlong Huang ◽

Xiaoyuan Gu ◽

Xianshang Zeng ◽

Baomin Chen ◽

Weiguang Yu ◽

...

Keyword(s):

Postmenopausal Women ◽

Survival Benefit ◽

Progression Free Survival ◽

Wild Type ◽

Free Survival ◽

Primary Endpoints ◽

Significant Difference ◽

Inductive Treatment ◽

Advanced Colorectal Carcinoma

Abstract Background An upgraded understanding of factors (sex/estrogen) associated with survival benefit in advanced colorectal carcinoma (CRC) could improve personalised management and provide innovative insights into anti-tumour mechanisms. The aim of this study was to assess the efficacy and safety of cetuximab (CET) versus bevacizumab (BEV) following prior 12 cycles of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus BEV in postmenopausal women with advanced KRAS and BRAF wild-type (wt) CRC. Methods Prospectively maintained databases were reviewed from 2013 to 2017 to assess postmenopausal women with advanced KRAS and BRAF wt CRC who received up to 12 cycles of FOLFOXIRI plus BEV inductive treatment, followed by CET or BEV maintenance treatment. The primary endpoints were overall survival (OS), progression-free survival (PFS), response rate. The secondary endpoint was the rate of adverse events (AEs). Results At a median follow-up of 27.0 months (IQR 25.1–29.2), significant difference was detected in median OS (17.7 months [95% confidence interval [CI], 16.2–18.6] for CET vs. 11.7 months [95% CI, 10.4–12.8] for BEV; hazard ratio [HR], 0.63; 95% CI, 0.44–0.89; p=0.007); Median PFS was 10.7 months (95% CI, 9.8–11.3) for CET vs. 8.4 months (95% CI, 7.2–9.6) for BEV (HR, 0.67; 95% CI 0.47–0.94; p=0.02). Dose reduction due to intolerable AEs occurred in 29 cases (24 [24.0%] for CET vs. 5 [4.8%] for BEV; p< 0.001). Conclusions CET tends to be superior survival benefit when compared with BEV, with tolerated AEs.

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One-Year Progression-Free Survival of Therapy-Naive Patients With Malignant Pheochromocytoma and Paraganglioma

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2013-1907 ◽

2013 ◽

Vol 98 (10) ◽

pp. 4006-4012 ◽

Cited By ~ 58

Author(s):

Ségolène Hescot ◽

Sophie Leboulleux ◽

Laurence Amar ◽

Delphine Vezzosi ◽

Isabelle Borget ◽

...

Keyword(s):

Evaluation Criteria ◽

Progression Free Survival ◽

Malignant Pheochromocytoma ◽

Inherited Disease ◽

High Power Field ◽

Free Survival ◽

History Of ◽

Wait And See ◽

One Year

Abstract Context: The natural history of malignant pheochromocytoma or paragangliomas (MPP) remain unknown. Objective: The primary aim of this study was to define progression-free survival at 1 year in therapy-naive patients with MPP. Secondary objectives were to characterize MPP and to look for prognostic parameters for progression at 1 year. Design and Setting: The files of MPP followed up between January 2001 and January 2011 in two French Endocrine Networks were retrospectively reviewed. Therapy-naive patients were enrolled. Main Outcome Measures: The main outcome was progression-free survival at 1 year in therapy-naive MPP patients according to Response Evaluation Criteria In Solid Tumors 1.1 criteria. Results: Ninety files (46 men, 44 women, mean age of 47.5 ± 15 years) were reviewed on site by one investigator. MPP characteristics were as follows: presence of an adrenal primary, a mitotic count exceeding 5 per high power field, hypertension, inherited disease, and presence of bone metastases in 50%, 22%, 60%, 49%, and 56% patients, respectively. Fifty-seven of the 90 patients with MPP (63%) were classified as therapy-naive. The median follow-up of these 57 patients was 2.4 years (range, 0.4–5.7). At 1 year, progression-free survival was 46% (CI 95: 33–59). Twenty-six of 30 (87%) patients with progression at 1 year had exhibited progressive disease at the first imaging workup performed after a median of 5.7 months. No prognostic parameter was identified. Conclusions: Half of the therapy-naive patients with MPP achieved stable disease at 1 year. In symptom-free patients with MPP, a wait-and-see antitumor policy seems appropriate as first line. Modality for a prospective follow-up is proposed.

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MNG-03 PD-L1 EXPRESSION, PATIENT PROGNOSIS AND INITIAL WHO GRADE IN GRADE II/III MENINGIOMA

Neuro-Oncology Advances ◽

10.1093/noajnl/vdz039.162 ◽

2019 ◽

Vol 1 (Supplement_2) ◽

pp. ii36-ii36

Author(s):

Dai Kamamoto ◽

Hikaru Sasaki ◽

Ryota Sasao ◽

Takumi Fujiyama ◽

Kazunari Yoshida

Keyword(s):

Radiation Therapy ◽

Progression Free Survival ◽

Who Grade ◽

Free Survival ◽

Specific Data ◽

Tumor Immune Evasion ◽

Significant Difference ◽

Grade Ii ◽

Patient Prognosis ◽

The Relationship

Abstract The optimal treatment for grade II/III meningioma is operation with or without radiation therapy. However, their natural course is sometimes aggressive with high recurrent rate. There is no effective treatment other than operation and radiation therapy, therefore, a new therapeutic strategy for grade II/III meningioma is urgently required.PD-1 and PD-L1 play important roles as immune-checkpoint mediators within tumor microenvironment and the antibodies to these molecules are now approved for the treatment of various kinds of cancers. In Japan, anti-PD-1 antibody and anti-CTLA-4 antibody are approved for unresectable melanoma or advanced / recurrent non-small cell lung cancer and their high effectiveness has been reported. We investigated the expression of PD-L1 (clone:28-8) in 51 cases of grade II/III meningioma by immunohistochemistry and analyzed the relationship between the expression with overall survival, progression free survival and initial WHO grade. For now, we have evaluated 25 cases of PD-L1 immunohistochemistry and PD-L1 showed positivity in 15 cases. There is no correlation observed between PD-L1 expression and patients’ prognosis. Although it does not reach a significant difference, the WHO grade at the time of initial operation tends to be high in those with high PD-L1 staining rate.Similar studies that were previously reported did not use antibodies targeting clone 28-8, which was used as a companion diagnosis for nivolumab administration, but “Correlation between PD-L1 expression and WHO grade”, or “PD-L1 expression is an independent prognostic factor” have been reported. In our investigation, which was using antibodies for companion diagnosis, PD-L1 was positive in more than half of Grade II / III meningiomas and it also related to WHO grade. These results suggest the possibility that tumor immune evasion mechanisms are also working in meningiomas. At the conference, we will report it with the specific data from all cases with a literature review.

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Bortezomib, Thalidomide, and Dexamethasone as Induction Therapy for Patients with Symptomatic Multiple Myeloma.

Blood ◽

10.1182/blood.v110.11.3605.3605 ◽

2007 ◽

Vol 110 (11) ◽

pp. 3605-3605 ◽

Cited By ~ 1

Author(s):

Jonathan L. Kaufman ◽

Charise Gleason ◽

Leonard Heffner ◽

Sagar Lonial

Keyword(s):

Induction Therapy ◽

Progressive Disease ◽

Response Rate ◽

Progression Free Survival ◽

High Response Rate ◽

High Dose ◽

High Dose Therapy ◽

Free Survival ◽

One Year

Abstract The optimal induction regimen for patients with symptomatic myeloma who are eligible for transplantation is currently unknown. While thalidomide and dexamethasone is an effective regimen, it only has a 60 to 65% response rate and few complete responses (CR). Bortezomib based inductions have demonstrated a high response rate and an improved CR as well. Recently the IFM reported the initial results of the randomized bortezomib plus dexamethasone versus VAD induction followed by transplant, which demonstrated that fewer patients treated with bortezomib required tandem transplants. Wang et al reported a high induction response rate with the combination of BTD for only 2 cycles given over a 28 day cycle. Here we report our experience with the combination of BTD as induction therapy. 38 patients with symptomatic myeloma were treated with BTD as induction therapy. Patients received standard dose and schedule bortezomib at 1.3 mg/m2 on days 1, 4, 8, and 11 with thalidomide at 100 mg/day, and 8 days of 40 mg dexamethasone every 21 days. The median age was 58 years (38–70) with 19 males. This was first line therapy for 29 patients, second line for 7 patients and 3rd line for 2. 12 patients had ISS stage 2 and 8 had ISS stage 3. The median β2M was 3.4 (1.66–41.89). Median creatinine was 1.1 (0.6–21.0). Nineteen patients had an IgG paraprotein, 6 an IgA, and 16 patients had light chain disease. The median number of cycles administered was 4 (2–8). Fifteen patients developed neuropathy of any grade. One patient developed grade 3 neuropathy. The overall response rate (CR, VGPR, plus PR) was 92%, with 58% of patients achieving a VGPR or better, and 21% of patients achieving an immunofixation negative CR. 1 patient had a minimal response and 2 patients had progressive disease (both patients presented with plasma cell leukemia). These two patients were treated with the combination of BTD with PACE chemotherapy. One of the two died from progressive disease and the other patient remains in complete remission after high dose therapy and autologous transplantation. 29 patients had consolidation therapy with high dose melphalan and autologous peripheral blood stem cell transplantation. Eight patients have collected stem cells without proceeding with immediate consolidation therapy. After a median follow up of 373 days, median progression free survival and overall survival have not been reached. One year overall survival is 97%. One year progression free survival is 87%. In conclusion, we report a very high response rate with a short course of bortezomib, thalidomide and dexamethasone with an acceptable toxicity profile. Follow up of patients in CR treated without high dose therapy and autologous transplant is in progress. Further studies of this active regimen are warranted.

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Immunologic Recovery after Autologous Transplant in Multiple Myeloma and Progression Free Survival

Blood ◽

10.1182/blood.v112.11.4444.4444 ◽

2008 ◽

Vol 112 (11) ◽

pp. 4444-4444

Author(s):

Fernanda Maria Rodrigues Trigo-Miranda ◽

Rui Cordeiro Bergantim ◽

Ricardo Moreira Pinto ◽

Patricia Guimarães ◽

Jose E. Guimaraes

Keyword(s):

Multiple Myeloma ◽

Progression Free Survival ◽

Response To Treatment ◽

Cell Transplant ◽

Haematopoietic Progenitor Cell ◽

Free Survival ◽

Post Transplant ◽

Historical Comparison ◽

Significant Difference

Abstract Several factors influencing disease progression and survival have been identified in multiple myeloma (MM). We analysed a series of 49 consecutive patients with MM that underwent autologous haematopoietic progenitor cell transplant (HPCT) in one center regarding the following variables: use of G-CSF for haematopoietic recovery post-transplant; recovery of normal IgM levels at day +100 post-transplant; levels of lymphocytes namely of the CD4+ and CD8+ subsets also at day +100. Before 2006, all patients had G-CSF starting 24 hours after the cell infusion until neutrophil > 500×10^9/L in two consecutive days; in the years 2006–2008, no G-CSF was given to transplanted patients. A historical comparison was done and at the time of this study no significant difference in progression free survival (Kaplan-Meyer analysis), was detected between the two groups, possibly due to the shorter follow-up of the “no G-CSF” (n=19) group; nevertheless median progression free survival (PFS) in the “G-CSF” group was 12 months while median PFS was not attained in the “no G-CSF” group (median follow-up = 7 months). Post transplant IgM levels were also determined in 39 patients. Eighteen patients recovered normal IgM levels at day +100 (46.8 %) and 21 (53.8 %) did not. Comparison of Kaplan-Meyer curves for the two groups did not show any statistically significant difference but there is a sharp difference between median PFS of the “low IgM” (10 months) and the “normal IgM” (27 months) groups. CD4/CD8 ratio was determined in 18 patients at day +100. The ratio varied between 0 and 0.63 (median – 0.305). No correlation was found between post-transplant IgM recovery and CD4/CD8 ratio. In conclusion, in our series of MM patients treated with autologous HPCT we could not find a definite relationship between immunologic recovery and response to treatment although there is a trend to a better outlook of the patients which recover normal IgM levels. It is also uncertain whether use of G-CSF in the post-transplant period would have any effect on disease behaviour.

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Efficacy of Yttrium-90 Zevalin Outside of Clinical Trials: Preliminary Results of a Retrospective Bi-Center Study

Blood ◽

10.1182/blood.v112.11.5015.5015 ◽

2008 ◽

Vol 112 (11) ◽

pp. 5015-5015

Author(s):

Francesco Cicone ◽

Francesco Scopinaro ◽

Sebastien Baechler ◽

Nicolas Ketterer ◽

Franz Buchegger ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Setting ◽

Patient Population ◽

Statistical Significance ◽

University Hospital ◽

Low Grade ◽

Number Of Patients ◽

Significant Difference ◽

Routine Clinical Setting

Abstract Background and Aim: Due to limited data regarding the efficacy of Radioimmunotherapy with 90Y-Zevalin (RIT-Z) outside of controlled clinical trials, we carried out a biinstitutional, international retrospective study to assess the efficacy of RIT-Z in a routine clinical setting. The relationship between the number of previous therapies and outcomes as well as the response to the last therapy was assessed. Possible differences in outcomes for patients treated in the two different centers were also analyzed. Materials and Methods: Forty-three consecutive patients treated at the University Hospital of Lausanne (CHUV, Switzerland) and at S. Andrea University Hospital of Rome (Italy) were evaluated, none of which had been previously included in clinical trials. Only 31 patients entered the final analysis: patients lost at follow up, undergoing autologous transplantation (ASCT), or treated within the last 3 months were excluded. Efficacy of therapy was evaluated in terms of Overall Survival (OS), Progression Free Survival (PFS), and Time to Next Treatment (TTNT). Survival curves were obtained with the Kaplan- Meier method (statistical significance = p<0.05). Results: Characteristics of the patient population are listed in Table 1. Although 50% of the patients had aggressive histologies, patients treated at S. Andrea had slightly more favorable features than those treated at CHUV. Fourteen patients (45%) had received at least 4 previous treatments, and all had received Rituximab. Fourteen patients (45%) had not responded to the last therapy, while 6 (19%), all treated at S.Andrea, were considered disease-free at the time of RIT-Z, which was administered for consolidation. Median follow up time was 20 months (11.5 vs. 25 months for S.Andrea and CHUV, respectively). Median PFS and TTNT were similar. After achieving a partial response, 2 patients were referred to Rituximab maintenance after RIT-Z and remain progression-free. Median OS was still not attained. Although not statistically significant, a trend towards better outcomes for S. Andrea patients was found. In comparing patients with indolent and aggressive lymphoma, only PFS was found to be significantly different (median PFS: 10 vs. 5 months, p<0.05). In patients with <4 and ≥ 4 previous therapies, twenty month OS was 88% vs. 53.6% (p=0.02), respectively; median TTNT was 22 vs. 5 months (p=0.013), while differences in PFS did not attain statistical significance. The duration of response in non-responders to their last therapy was shorter than in responders: 20-month OS- 44% vs. 94% (p=0.0015), median PFS and TTNT- 3.5 vs. 15 months (p=0.0002) and 4 vs. 15 months (p=0.0001), respectively. Median PFS and TTNT after RIT-Z did not differ from those found after the last therapy. A significant difference in outcomes for heavily pretreated or refractory patients was found in those with low grade follicular lymphoma. Conclusions: Poorer outcomes were found in our patient population treated in a routine clinical setting compared to those enrolled in clinical trials. This may be related to greater heterogeneity of our study cohort which included more patients with unfavorable conditions (e.g. aggressive NHL, ≥4 treatment courses including rituximab in all, and ASCT in 25%). Our results suggest that the best benefit may be expected with RIT-Z either for consolidation or relatively earlier in the course of NHL treatment. Table 1. Total CHUV S. Andrea Population Analyzed (72%) Number of patients 43 23 20 31 Median Age 61 63 58,5 62 Aggressive Histology (FL grade 3 or DLBCL) 18 (41,8%) 8 (34,7%) 10 (50%) 11 (35,5%) Indolent Histology (FL grade 1 or 2) (%) 25 (58,2%) 15 (65,3%) 10 (50%) 20 (64,5%) Patients with ≥4 previous treatments 19 (44,2%) 12 (52,1%) 7 (35%) 14 (45,2%) Patients with previous ASCT 11 (25,6%) 6 (26%) 5 (25%) 8 (25%)

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Radiation-associated versus sporadic osteosarcoma: A single-institution experience.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.11018 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 11018-11018

Author(s):

Brittany Siontis ◽

Emily Roberts ◽

Lili Zhao ◽

Jonathan B. McHugh ◽

Dawn Owen ◽

...

Keyword(s):

Rare Complication ◽

Progression Free Survival ◽

Primary Malignancy ◽

Free Survival ◽

Significant Difference ◽

Detectable Difference ◽

History Of ◽

Median Cumulative Dose ◽

Worse Prognosis

11018 Background: Osteosarcoma (osarc) can be a rare complication from radiation (rt) therapy. Radiation-associated osarc (RAO) is reported to have a worse prognosis than non rt-associated osarc with limited objective data comparing the two. We conducted a retrospective study comparing demographics, therapy and outcomes of sporadic osarc (SO) to RAO. This study was confined to adults. Methods: We identified patients (pts) > age 18 years (yr) with osarc treated at our institution between 1990 and 2016 using an institutional database. We categorized tumors as SO or RAO based on history of prior rt within field of osarc. We extracted data on demographics, treatment, and primary malignancy characteristics. Results: We identified 159 pts with osarc, 28 were RAO tumors. Results are in Table 1. Median follow-up was 2.8 yr (0.1-19.6 yr). For RAO, median time from rt to diagnosis was 11.5 yr (1.5-28 yr) with a median cumulative dose of 60 Gy (44-75.8 Gy). Median progression free survival (PFS) and overall survival (OS) were not significantly different in pts presenting with metastatic osarc; PFS 10.3 mo vs 4.8 mo (p=0.45) and OS 15.6 mo vs 6.1 mo (p=0.96) in SO vs RAO pts, respectively. For pts with localized osarc, median relapse-free survival (RFS) and OS were significantly different, not reached vs 12.2 mo (p<0.001) and not reached vs 27.6 mo (p=0.001) in SO vs RAO, respectively. Conclusions: In our series, there was a significant difference in age, size and location of RAO vs non rt-associated osarc. Overall, all osarc pts with metastatic disease at diagnosis fared poorly. Pts presenting with localized RAO had worse outcomes than patients with localized SO. This was not associated with a detectable difference in therapy rendered or treatment effect in resection specimens. [Table: see text]

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Current treatment strategies and patterns of recurrence in locally advanced colon cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15171 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15171-e15171

Author(s):

Caroline Huynh ◽

Stephanie Minkova ◽

Diane Kim ◽

Heather Stuart ◽

Trevor D Hamilton

Keyword(s):

Colon Cancer ◽

Locally Advanced ◽

Positive Margin ◽

Curative Intent ◽

Free Survival ◽

Node Negative ◽

Entire Cohort ◽

Advanced Colon Cancer ◽

Patterns Of Recurrence

e15171 Background: Locally advanced colon cancer (LACC) is a frequent presentation and has a high rate of recurrence. The aim of this study was to evaluate current population-based strategies in LACC patients, and to analyze patterns of recurrence. Methods: We conducted a retrospective review of all patients treated at a regional cancer agency with a diagnosis of LACC between 2005 and 2015 treated with curative intent resection. Inclusion criteria were adults with T4 colon cancer, 16 cm above the anal verge, with no evidence of distant metastases. Descriptive statistics were used to define the study population. Kaplan-Meier and Cox-proportional hazards modeling were used for survival analysis. Results: 1394 patients with LACC were reviewed. Median age was 69 [IQR 60-77] and 49.3% were female. Primary tumor location was right-sided in 57.1% of cases. Most tumors were T4a (69.4%) and 39.4% were node positive. A total of 35.4% had urgent/emergent surgery, 46.4% were at least partially obstructed, 22.0% were perforated and 1.9% had a diverting ostomy as an initial operation. En-bloc multi-visceral resection occurred in 23.5% of cases. Positive margins were present in 14.3%. Only 1.6% had neoadjuvant chemotherapy and 0.8% had neoadjuvant chemoradiation. Adjuvant chemotherapy was delivered in 59.8% and adjuvant chemoradiation in 2.8%. Median follow up was 37 months. During follow up 681 (48.9%) patients died and 584 (41.9%) patients developed recurrence. In the entire cohort, rates of recurrences were local-regional (14.7%) and distant metastatic (35.1%). Overall survival for the entire cohort was 63 months [95% CI 55.7-70.3] and recurrence-free survival was 61 months [95% CI 38.8-83.2]. Multivariate analysis identified age (HR 1.03, 95% CI [1.02-1.05] p < 0.001), node negative status (HR 0.62, 95% CI [0.45-0.84] p = 0.002) and positive margin (HR 1.79, 95% CI [1.24-2.57] p = 0.002) as predictive of overall survival after adjusting for confounding factors. Predictive factors for recurrence-free survival were node negative status (HR 0.55, 95% CI [0.39-0.77] p < 0.001) and positive margin (HR 1.51, 95% CI [1.02-2.23] p = 0.038). Conclusions: Recurrence after curative intent treatment for LACC is common. Recurrence and survival patterns are significantly influenced by tumor nodal status and margin positivity.

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Survival of patients with cervical cancer and diabetes: An exploratory study.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e17008 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e17008-e17008

Author(s):

Maria Luisa Romero ◽

Jose Luis Gonzalez Vela ◽

David Hernandez Barajas ◽

Ascary Velazquez-Pacheco ◽

Abrham Josafath Hernández ◽

...

Keyword(s):

Cervical Cancer ◽

Statistical Significance ◽

Clinical Stage ◽

Locally Advanced ◽

Progression Free Survival ◽

Free Survival ◽

Glycemic Level ◽

Metformin Group ◽

Group 2

e17008 Background: Mexico is the sixth country with the highest number of diabetics, this being the second cause of death. Between 8-18% of cancer patients have Diabetes (DM) as comorbidity. Studies have reported DM has worst prognosis in Overall Survival (OS) and Progression Free Survival (PFS) in patients with Cervical Cancer (CC). Aim: to compare OS in patients (pt) with a diagnosis of CC and DM, and to evaluate this outcome in relation to the clinical stage and the glycemic level at diagnosis of CC. Methods: data was obtained from pt treated for invasive CC between 2006 and 2016. Pt aged ≥20 years, with squamous, adenocarcinoma or adenosquamous histology. 59 pt with CC and DM in group 1 (G1), and 118 pt with CC without DM in group 2 (G2), paired 1:2 according to clinical stage, age and comorbidities. Results: Prevalence of DM in pt with CC was 16%. Follow-up of 142.2 months (median of 40.4 months), lower OS for G1 was seen (74.6% vs 77.1%), without statistical significance (p.803). PFS was similar for both groups (67.8% G1 vs 66.9% G2, p .608). In patients with locally advanced and metastatic disease, a lower OS and PFS were found in G1, without statistical significance. 42.4% diabetic pt had glycemic level < 130 mg / dL). OS was lower in pt with higher glycemic level (70.6% vs 80%), not being statistically significant (p .32). PFS was similar in both groups (G1: 68% vs G2: 67.6%, p.852). Analysis for influence of metformin treatment, evidenced a higher OS among pt receiving metformin (84.8% vs 61.5%), without statistical significance (p 0.65). PFS was higher in the metformin group (78.8 vs 53.8%), with a trend towards statistical significance (p .052). Conclusions: Pt diagnosed with CC and DM do not have different OS compared to those without DM. There was a tendency towards the improvement of PFS in pt with CC and DM, who received metformin.

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Follow-up Analysis of Ixazomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Routine Clinical Practice

Blood ◽

10.1182/blood-2021-148836 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 2716-2716

Author(s):

Jiri Minarik ◽

Jakub Radocha ◽

Alexandra Jungova ◽

Jan Straub ◽

Tomas Jelinek ◽

...

Keyword(s):

Clinical Practice ◽

Research Funding ◽

Previous Analysis ◽

Progression Free Survival ◽

Routine Clinical Practice ◽

Toxicity Profile ◽

Advisory Committees ◽

Free Survival ◽

Significant Difference

Abstract Background: The addition of ixazomib to the doublet lenalidomide and dexamethasone (RD) in relapsed and refractory multiple myeloma (RRMM) has shown significant benefit in progression free survival (PFS) in the TOURMALINE-MM1 study. Several real-world data including our previous analysis confirmed that the combination IRD is feasible and with fair outcomes even outside the clinical trial. Here we report an updated analysis which is aimed at overall survival (OS) and the PFS2 interval which is defined as the time from the date of treatment initiation to the date of first documentation of progressive disease after initiation of further anti-myeloma treatment or death from any cause. Methods: We analyzed a cohort of 344 patients with RRMM, 127 being treated by IRD and 217 by RD combination. The group characteristics and study design are described elsewhere. 1 The median follow-up of the whole cohort was 28.5 months. The primary endpoint was OS, OS in patients with relapse 1-3, progression free survival (PFS), and PFS2. Secondary endpoints were response rates and toxicity profile. For statistical analysis we used Fisher's exact test or Mann-Whitney U test. Survival measures were assessed using the Kaplan-Meier methodology, and statistical significance was assessed using the log-rank test at a significance level of α = 0.05 (all tests two-sided). Results: The outcomes of OS in the whole cohort were already published before, with significantly longer median OS in the IRD vs RD cohort (mOS 36.6 months vs 26.0 months, p = 0.008).1 In the follow-up analysis, the medians were slightly improved, maintaining a significant difference (mOS 40.9 vs 27.1 months, p = 0.001). In patients treated within relapse 1-3, the results outcomes were even more pronounced (mOS 51.7 vs 27.8 months, p ˂ 0.001). The median PFS was also better in the IRD cohort (mPFS 17.5 vs 12.5 months, p = 0.013) but the results did not substantially differ from our previous analysis. The median PFS2 in the IRD vs RD cohort was significantly longer in the IRD cohort (mPFS2 29.8 vs 21.6 months, p = 0.016). The subsequent therapy included mostly pomalidomide (27.5% vs 30.8%), bortezomib (28.8% vs 28.2%) or thalidomide (10.0% vs 16.2%). Monoclonal antibodies (daratumumab, isatuximab) were more frequently used after IRD combination (21.3% vs 4.3%). The response rates in the IRD vs RD cohort were similar as in our primary analysis: overall response rate (ORR) 73.0% vs 66.8%, with significant difference in very good partial response and better (VGPR+) 38.1% vs 26.3%. The toxicity profile did not reveal any additional safety concerns. Majority of grade 3+ toxicities included hematological toxicity (anemia, neutropenia, thrombocytopenia) and infections, with similar distribution in the cohorts. Conclusion: The treatment of RRMM using the full oral IRD regimen in routine clinical practice is easy, safe and with significantly improved outcomes in comparison to RD doublet. Our follow-up analysis confirmed the impact on OS in patients in the whole cohort including relapse 1-3. The median PFS2 was also longer in the IRD cohort, possibly affected by more frequent use of monoclonal antibodies in the next treatment. With support of AZV 17-29343A, NV18-03-00500, MH CZ - DRO (FNOl, 00098892), IGA-LF-2021-001. 1) Minarik J, Pika T, Radocha J. et al. Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice. BMC Cancer 2021; 21: https://doi.org/10.1186/s12885-020-07732-1 Disclosures Minarik: Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria. Hajek: Novartis: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Pharma MAR: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

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