Interplay of grade and stage on survival outcomes in appendiceal adenocarcinoma: Corroboration of the AJCC (8th edition) Cancer Staging Classification.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 773-773
Author(s):  
Kanwal Pratap Singh Raghav ◽  
Keith F. Fournier ◽  
Benny Johnson ◽  
Melissa W. Taggart ◽  
Wai Chin Foo ◽  
...  
Keyword(s):  
Histological Grade ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Cancer Staging ◽  
Stage Ii ◽  
Prognostic Impact ◽  
Ajcc Stage ◽  
Grade 3 ◽  
Staging Classification ◽  
8Th Edition

773 Background: Histological grade is a key prognostic factor in appendiceal adenocarcinomas (AAs) and has been incorporated in classification of stage IV AAs (IVA – Grade 1: Well; IVB – Grade 2/3: Moderately/Poorly differentiated) in AJCC Cancer Staging (8th edition). The purpose of the study was to corroborate the prognostic impact of this staging classifier. Methods: We performed a retrospective review of 98 AA patients (pts) at UTMDACC (2013 - 2017). Kaplan-Meier method was used to estimate median overall survival (mOS), compared with log-rank tests with emphasis on stage and grade. Results: The cohort included 18, 8, 14, 47 and 11 cases of stage II, III, IVA, IVB and IVC AAs. Histologically, 75 were mucinous (21 non mucinous) and 19, 35 and 42 were grade 1, 2 and 3 respectively. Median age of cohort was 54 years. Median follow-up was 46 months (m). The mOS of stage II, III, IVA, IVB and IVC was 136, 106, 140, 48, 23 m, respectively (P < 0.0001). The mOS of grade 1, 2 and 3 was 160, 75 and 33 m, respectively (P < 0.0001). In univariate analysis (restricted to stage IV pts), grade, AJCC stage, and cytoreductive surgery (CRS) were found to be associated with OS. In multivariate analyses (restricted to stage IV pts), only AJCC stage (HR 3.9, 95% CI: 1.5 - 10.6, P = 0.005) and CRS (HR 3.4, 95% CI: 1.4 – 8.3, P = 0.009) were found to be independently associated with poor OS. In subgroup of mucinous AAs, mOS of grade 3 (32 m) was significantly shorter than grade 2 (54 m) (P = 0.02). In non-mucinous AAs, mOS of grade 3 and grade 2 pts was 38 and 29 m, respectively (P = 0.97). Conclusions: AJCC staging classification has a strong prognostic value in AAs. Beyond the well differentiated AAs which are regarded as a distinct entity in stage IV disease, moderate and poor differentiation also has strong and dissimilar prognostic impact which appears to be dependent on mucinous or non-mucinous subtype in stage IV AAs. Further efforts are needed to incorporate the complex interplay of all grades and mucinous characteristics within the staging system for better prognostication and management.

scholarly journals Prognostic Impact of Pathological Adverse Features in Surgically Resected Adenocarcinoma of Esophagogastric Junction

2021 ◽  
Author(s):  
Qianchao Liao ◽  
Jiabin Zheng ◽  
Wenjun Xiong ◽  
Junjiang Wang ◽  
Xu Hu ◽  
...  
Keyword(s):  
Risk Factor ◽  
Esophagogastric Junction ◽  
Independent Risk Factor ◽  
Univariate Analysis ◽  
Stage Ii ◽  
Prognostic Impact ◽  
Provincial Hospital ◽  
Adenocarcinoma Of Esophagogastric Junction ◽  
The Status ◽  
Poor Differentiation

Abstract Objective The prognostic value of lymphovascular invasion (LVI), perineural invasion (PNI), and poor differentiation (PD) has been widely studied in different solid tumors. However, it was still controversial in adenocarcinoma of esophagogastric junction (AEG). We investigated the prognostic impact of combining LVI, PNI and PD for predicting the survival in patients with AEG.Methods We retrospectively investigated the data of patients who performed surgical resection of AEG on Guangdong Provincial Hospital and Guangdong Provincial Hospital of Chinese Medicine from Jan. 2004 to Dec. 2018. According to the status of LVI, PNI and differentiation, pathological adverse features were divided into three groups: 0, 1 or 2 and 3 adverse features, their impact on prognosis was evaluated. Results Univariate analysis indicated pT, pN, LVI , PNI , PD and pathological adverse features were risk factors for both overall survival (OS) and disease-specific survival (DSS), and multivariate analysis indicated that pathological adverse feature was independent risk factor for both OS and DSS. In subgroup analyses, adverse features were independent risk factor for DSS of stage II AEG but not for stage I or III.Conclusions The pathological adverse features were independent prognostic factors for AEG patients and they can help for further risk stratification in stage II patients.

Intra-Follicular Proliferation Rate Is a Powerful Independent Prognosticator in Follicular Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4571-4571
Author(s):  
Ad Koster ◽  
Hedwig A. Tromp ◽  
John M. Raemaekers ◽  
George F. Borm ◽  
Marius A. MacKenzie ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Univariate Analysis ◽  
Proliferation Rate ◽  
Rank Test ◽  
Low Grade ◽  
Prognostic Impact ◽  
Bulky Disease ◽  
Histologic Grading ◽  
Grade 3 ◽  
Mib 1

Abstract Several prognostic scores are used to predict the outcome of patients with follicular lymphoma (FL). Histologic grading is widely used, but poorly reproducible. Scoring systems such as the (FL)IPI consist of surrogate clinical markers that probably reflect underlying biological phenomena. We hypothesized that the proliferation rate of the intra-follicular neoplastic cells in FL may predict clinical outcome. Proliferating cells were identified by using the Mib-1 antibody in pre-treatment lymph node biopsies of 51 patients. In each section 200 cells per follicle were assessed in five follicles. The proliferation ratio (PR) was defined as (no. of Mib-1 positive cells/ total no. of cells) x 100. The PR was assessed only in the follicles, since many proliferating, non-malignant cells are present in the inter-follicular area. The inter-observer variability was assessed by repeating this procedure for 25 cases by a second investigator blinded to the outcome of the first assessment, resulting in a correlation coefficient of 0.81 (p &lt; 0.001). All patients participated in a prospective multicenter trial on first-line treatment with the combination of 8 cycles of CVP (cyclophosphamide, vincristine and prednisone) chemotherapy plus interferon-alpha2b, followed by interferon-alpha maintenance in responding patients until relapse or progression. For statistical analysis the Kaplan-Meier product limit method, the log-rank test, the Cox proportional hazard model and the Mann-Whitney-U test were used. The median age of the patients was 53.3 years; 37 patients had stage IV disease; in nine patients a wait and see interval preceded the treatment (median duration 13 months). A low IPI score was present in 27 patients, intermediate in 20 and high in one. (three patients unknown). After central revision of the original diagnosis six patients were classified as grade 3 FL, 45 as grade 1 or 2. The overall median PR was 16.9 (3.1–49.2). In grade 1 and 2 FL the median PR was 16.1, in grade 3 it was 24.2 (p = 0.02). After a median follow-up of 71 months the median progression-free survival (PFS) for all patients was 25 months. The median PFS was not reached in the patients with the PR below the median compared to only 15 months in the patients with the PR above the median (p = 0.00059). In patients with the PR below median, overall survival was not reached compared to only 42 months in patients with a high PR (p = 0.0019). The PR maintained its prognostic impact on PFS and OS when tested as a continuous variable (p = 0.016 and 0.053 resp.). When the six patients with grade 3 FL were excluded from the analysis, the results remained significant. Other parameters that were significantly associated with a worse OS in univariate analysis were male sex, the presence of bulky disease and intermediate or high IPI. In multivariate analysis the association of high PR with a worse OS remained significant. We found that in FL intra-follicular proliferation rate is a strong independent prognostic factor of PFS and OS. Grade 3 FL appeared to have a higher PR than low grade FL, although numbers are small in this study. PR assessment is easy, relatively fast and reproducible. When confirmed in larger series, the intra-follicular PR could be used instead of histologic grading in identifying the aggressive types of follicular lymphoma, requiring other types of treatment.

Improving the AJCC/TNM staging for adenocarcinomas of the appendix: The prognostic impact of histologic grade.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 402-402
Author(s):  
Michael J. Overman ◽  
Keith F. Fournier ◽  
Chung-Yuan Hu ◽  
Robert A. Wolff ◽  
Cathy Eng ◽  
...  
Keyword(s):  
Histological Grade ◽  
Stage Iv ◽  
Tnm Staging ◽  
Cox Proportional Hazards ◽  
Disease Stage ◽  
Prognostic Impact ◽  
Cancer Specific Survival ◽  
Mucinous Histology ◽  
Stage Iv Disease ◽  
Poorly Differentiated

402 Background: Though histological grade is known to have a major prognostic impact in metastatic mucinous appendiceal adenocarcinomas; the prognostic impact of grade in localized disease, and the validity of the AJCC Cancer Staging Manual 7th edition decision to combine moderately and poorly differentiated mucinous adenocarcinomas into a single mucinous high-grade category, is not known. Methods: Patients with adenocarcinoma of the appendix diagnosed between 1988-2007 were identified from the SEER database. Cancer-specific survival (CSS) stratified by histological subtype, stage and grade were calculated; and Cox proportional hazards regression analyses were performed. Results: We analyzed a total of 2,469 appendiceal adenocarcinomas, of which 1,375 had mucinous histology, 860 had non-mucinous histology, and 234 had signet-ring cell histology. Though overall CSS was similar for mucinous and non-mucinous subtypes, differences in stage distribution and stage-stratified CSS were seen. Female gender (57% vs.45%, P<0.01), stage IV disease (48% vs. 25%, P<0.01), and well differentiated histology (31% vs. 14%, P<0.01) were more common in mucinous as compared to non-mucinous adenocarcinomas. While histological grade for stage I-III cases was not statistically significant, it had strong prognostic impact for stage IV disease. The adjusted hazard ratios for stage IV well, moderately and poorly differentiated histological grade were 1 (reference), 1.63 (95%CI: 1.14-2.34) and 4.94 (95%CI: 3.32-7.35) for mucinous, in comparison to 1 (reference), 1.44 (95%CI: 0.82-2.52) and 1.90 (95%CI: 0.95-3.80) for non-mucinous histological subtypes, respectively. Conclusions: The strong prognostic impact of histological grade for mucinous adenocarcinomas is primarily restricted to stage IV disease. Stage IV moderately and poorly differentiated mucinous adenocarcinomas have distinctly different CSS and this data does not support the combination of these two histological grades in the recent AJCC 7th edition.

scholarly journals Clinical Profile and Treatment Outcomes in Patients Treated with Intensity-Modulated Radiotherapy (IMRT) for Carcinoma Nasopharynx: A Retrospective Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Farida Nazeer ◽  
R. Rejnish Kumar ◽  
Malu Rafi ◽  
Tapesh Bhattacharya ◽  
Aparna Mullangath Prakasan ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Distant Metastasis ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Stage Iv ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iii ◽  
Pattern Of Failure ◽  
Free Survival

Objective. To retrospectively evaluate the clinical outcome of carcinoma nasopharynx patients treated with the IMRT technique. Methods. Eighty-one nasopharyngeal carcinoma patients who were treated with IMRT with or without chemotherapy between the period January 2011 and December 2014 at a comprehensive tertiary cancer center, Kerala, India, were included in the study. The mean age was 43 years (range 13–77 years), and majority of the patients were males (67.9%). The stagewise distribution of disease at presentation was 2 (2.5%) in stage I, 19 in stage II (23.5%), 31 (38.3%) in stage III, and 29 (35.8%) in stage IV. All patients were treated using simultaneous integrated boost (SIB) schedule using IMRT with 6 MV photon to a dose of 66 Gy in 30 fractions, 2.2 Gy per fraction prescribed to high-risk PTV; 60 Gy in 30 fractions, 2 Gy per fraction to intermediate risk PTV; and 54 Gy in 30 fractions, 1.8 Gy per fraction to low-risk PTV. Concurrent chemotherapy with cisplatin was offered to patients with stage II and above disease. Neoadjuvant chemotherapy with cisplatin and 5FU was given to patients with initially advanced disease (T3, T4, N2, and N3). Survival estimates were generated using the Kaplan–Meier method. The univariate analysis was performed using log-rank tests. Results. The 5-year locoregional control (LRC), distant metastasis-free survival (DMFS), disease-free survival (DFS), and overall survival (OS) rates were 87.5%, 87%, 61.6%, and 62.5%, respectively. The 5-year OS was 100% for stage I (n = 2), 67% for stage II (n = 19), 70.4% for stage III (n = 31), and 68.1% for stage IV (n = 29). The DFS at 5 years was 100% for stage I, 61.1% for stage II, 56.2% for stage III, and 84.8% for stage IV disease. The univariate analysis showed that age, nodal stage, and use of induction chemotherapy showed an improved trend towards OS, though the results were not statistically significant. The predominant pattern of failure in the present study was distant metastasis. Most patients who developed distant metastasis in our study had either an advanced T stage or N3 disease at presentation. Conclusion. The present study shows our initial experience with IMRT for nasopharyngeal carcinoma. The compliance to RT was good in this study. The 5-year LRC and OS rate of nasopharyngeal carcinoma patients treated with IMRT were 87.5% and 62.5%. Distant metastasis was the main pattern of failure.

Clinical and prognostic features of adult patients with gangliogliomas.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2063-2063
Author(s):  
Shlomit Yust-Katz ◽  
Mark Daniel Anderson ◽  
Diane Liu ◽  
Ying Yuan ◽  
Greg Fuller ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Histological Grade ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Tumor Grade ◽  
Histologic Grade ◽  
Low Grade ◽  
Prognostic Features ◽  
Grade 3 ◽  
The Impact

2063 Background: Gangliogliomas (GG) represent less than 1% of primary brain tumors in adults. Little is known regarding prognostic features, clinical characteristics or the impact of treatment on patient (pt) outcomes. Methods: In this IRB approved retrospective study, our neuro-oncology longitudinal database was screened for pts with GG from 1992-2012. 67 adult pts (age>18) were identified. Results: 60 pts presented with low grade GG and 7 with anaplastic GG. The median age at diagnosis was 27 years (18-59). 22 pts developed recurrent disease (18 low grade and 4 high grade) with a median time to recurrence of 87 weeks from surgery. 7 of the pts with low grade GG had malignant transformation to a malignant tumor (anaplastic GG or GBM). 22 pts received radiation therapy, 16 at diagnosis. 14 pts received chemotherapy at recurrence. Pts with incomplete resections or higher grade tumors were more likely to receive chemotherapy or radiation. The median overall survival (OS) time for these pts was not reached with a median follow-up time of 4.6 years. The 2-, 5- and 10-year OS were 98%, 87%, and 76%. Factors on univariate analysis that were significantly associated with OS were KPS at presentation (HR 10.1; 95% CI 2.6, 39.1; p = 0.0008), extent of resection (EOR) (biopsy vs gross total; HR 12.1; 95% CI 2.3, 63.6; p = 0.003), histologic grade (Grade 1-2 vs Grade 3-4; HR 0.06; 95% CI 0.01, 0.3; p = 0.0002), and seizure control following surgery (Engel I vs Engel 2-3; HR 0.1; 95% CI 0.01, 0.9; p = 0.02). Factors on univariate analysis that were significantly associated with progression free survival (PFS) were EOR (biopsy vs gross total; HR 4.0; 95% CI 1.4, 11.9; p = 0.01) and histologic grade (Grade 1-2 vs .Grade 3-4; HR 0.3; 95% CI 0.08, 0.8; p = 0.02). On multivariate analysis, EOR is most significant for PFS (p = 0.01), while tumor grade is most significant for OS (p = 0.004). Conclusions: While GG have an excellent prognosis, malignant histological grade, diagnosis with a biopsy only, poor initial KPS, and presence of seizures following surgery could indicate a worse prognosis. The role of chemotherapy and radiation therapy for incompletely resected or inaccessible low grade GG is unclear.

Allogeneic Stem Cell Transplantation (alloSCT) and Donor Lymphocyte Infusion (DLI) In Patients with Non-Hodgkin Lymphoma (NHL) Who Experienced Relapse or Progression After Autologous Stem Cell Transplantation (autoSCT): Retrospective Analysis From the Korean Society of Blood and Marrow Transplantation

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3536-3536 ◽  
Author(s):  
Ji-Won Kim ◽  
Byung-Su Kim ◽  
Soo-Mee Bang ◽  
Inho Kim ◽  
Dong Hwan Kim ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Analysis ◽  
Stem Cell ◽  
Serum Albumin ◽  
Cell Lymphoma ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Grade 3 ◽  
Ecog Ps ◽  
Significant Factors

Abstract Abstract 3536 Prognosis of patients with NHL who underwent relapse or progression after autoSCT is generally dismal and treatment option is limited. AlloSCT has been performed to overcome this problem and long term survivors have been reported. However, substantial transplant-related mortality (TRM) is a significant problem. We report clinical outcomes of alloSCT in these patients and DLI after failure of alloSCT along with analysis of risk factors for treatment results and adverse events. This retrospective study was performed in 7 hospitals in Korea. Candidate risk factors were age, sex, histology, Ann Arbor stage at diagnosis, number of prior treatments, time to progression (TTP) after autoSCT, bone marrow involvement, Eastern Cooperative Oncology Group (ECOG) performance status (PS), donor type, stem cell source, conditioning regimens of alloSCT, serum lactate dehydrogenase (above 250 IU/L), serum albumin (above 3.0 g/dL), and acute graft-versus-host disease (aGvHD). Between August 1998 and March 2009, 38 patients received alloSCT. Median age was 37 (range, 17–54) years. Male to female ratio was 26:12. Eighteen patients (47.4%) had B-cell lymphoma and 20 patients (52.6%), T/NK-cell lymphoma. Before alloSCT, patients had received median 4 (range, 2–7) prior treatments including autoSCT. Median TTP after autoSCT was 5.9 (range, 0.8–35.8) months. Twenty four patients (63.2%) received stem cells from related donors and 14 patients (36.8%) from unrelated donors. Median number of CD34+ cells infused was 5.41 × 106 (range, 0.86 × 106-16.60 × 106) /kg. Eighteen patients (47.4%) underwent a myeloablative conditioning and 20 patients (52.6%), a reduced intensity conditioning. During a median follow-up of 45.2 (range, 1.3–137.1) months, 24 patients (63.2%) experienced treatment failure and 22 patients (57.9%) died. Median event-free survival (EFS) was 6.3 (95% confidence interval (CI), 4.3–8.4) months. Median overall survival (OS) was 19.0 (95% CI, 3.8–34.2) months. Estimated 5-year survival rate was 35.0% (Figure). Treatment response was evaluable in 30 patients. Response rate was 73.3%; complete remission (CR) was achieved in 20 patients (66.7%) and partial response in 2 patients (6.7%). Grade 3 or 4 renal toxicity developed in 6 patients (15.8%), grade 3 or 4 hepatic toxicity in 15 patients (39.5%) including veno-occlusive disease (VOD) in 6 patients (15.8%), aGvHD in 13 patients (34.2%), and neutropenic fever in 34 patients (89.5%) including documented sepsis in 11 patients (28.9%). TRM was reported in 8 patients (21.1%). Causes of TRM were infection in 7 patients and VOD in 1 patient. In univariate analysis, no significant association was found with treatment response. By contrast, EFS was related to stage (p=0.039), TTP after autoSCT (p=0.033), and PS (p<0.001). OS was associated with stage (p=0.037), number of prior treatments (p=0.049), TTP after autoSCT (p=0.032), PS (p<0.001), and serum albumin (p=0.016). On the other hand, aGvHD was not associated with EFS (p=0.545) and OS (p=0.476). Multivariate analysis demonstrated that stage IV (hazard ratio (HR) 2.85 (95% CI, 1.13–7.22); p=0.027) and ECOG PS 2 (HR 3.94 (95% CI, 2.08–7.47); p<0.001) were significant factors for EFS and that stage IV (HR 3.28 (95% CI, 1.19–9.04); p=0.022), ECOG PS 2 (HR 5.26 (95% CI, 2.22–12.48); p<0.001), and serum albumin above 3.0 g/dL (HR 0.15 (95% CI, 0.03–0.63); p=0.010) were significant factors for OS. TRM was associated with PS (p=0.010) and serum albumin (p=0.040) by univariate analysis. Multivariate analysis showed that ECOG PS 2 was the only significant factor for TRM (relative risk (RR) 11.77 (95% CI, 1.43–97.01); p=0.022). ECOG PS 2 was also a significant factor for documented sepsis (RR 7.14 (95% CI, 1.08–47.42); p=0.042). DLI was performed in 8 patients who failed alloSCT. After median 1.5 (range, 1–6) cycles of DLI, 2 patients achieved CR. Grade III or IV aGvHD developed in these patients. By contrast, among 6 patients who failed to achieve CR, aGvHD developed in 2 patients. In conclusion, alloSCT is a viable option for patients with NHL who failed autoSCT despite high TRM. Stage and PS were significant factors for EFS and OS. Serum albumin was a significant factor for OS. In patients with ECOG PS 2, alloSCT should be avoided and novel treatment approaches should be offered due to high risk of TRM. DLI after failure of alloSCT showed promising results, which supports the presence of graft-versus-lymphoma effect. Disclosures: No relevant conflicts of interest to declare.

Outcomes of Thymoma Treated with Multimodality Approach: A Tertiary Cancer Center Experience of 71 Patients

2015 ◽  
Vol 103 (6) ◽  
pp. 572-576 ◽  
Author(s):  
Pramod K. Julka ◽  
Daya N. Sharma ◽  
Supriya Mallick ◽  
Ajeet K. Gandhi ◽  
Nikhil P. Joshi ◽  
...  
Keyword(s):  
Myasthenia Gravis ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Prognostic Significance ◽  
Stage Iv ◽  
Stage Ii ◽  
Cancer Center ◽  
Entire Cohort ◽  
Masaoka Stage ◽  
Multimodality Approach

Aims To explore the demographics and clinical outcome of patients with thymoma treated with a multimodality approach at our institute. Methods A total of 71 patients with thymoma (Masaoka stage II-IV and WHO subtype AB-B3) treated from 1999-2013 were included in this retrospective analysis. Age, stage, WHO subtypes, details of surgery, radiotherapy, and chemotherapy were noted. Progression-free survival (PFS) was estimated using Kaplan-Meier method and SPSS (version 21.0) was used for statistical analysis. Results Male:female ratio was 56:15 with median age at presentation of 41 years. Stage-wise distribution was 6:46:19 for stage II, stage III, and stage IV, respectively. A total of 31 patients (44%) had associated myasthenia gravis and 3 had pure red cell aplasia. A total of 57 patients (80%) underwent radical thymectomy and all of these patients received adjuvant radiotherapy. A total of 15 patients and 7 patients received adjuvant chemotherapy and neoadjuvant chemotherapy, respectively. At median follow-up of 19.3 months (range 7.9-72.3 months), 2-year and 3-year PFS rate for the entire cohort was 78.3% and 57.1%, respectively. On univariate analysis, surgery (hazard ratio [HR] 3.881; 95% confidence interval [CI] 1.784-19.220; p = 0.006) and stage (HR 5.457; 95% CI 1.567-18.996; p = 0.0001) were significant prognostic factors and association with myasthenia gravis (HR 0.404; 95% CI 0.151-1.078; p = 0.078) trended towards better PFS. Stage retained its prognostic significance (HR 5.501; 95% CI 2.076-14.573; p = 0.0006) on multivariate analysis. Conclusions Multimodality management of locally advanced thymoma yields decent survival outcomes. Masaoka stage is an independent prognostic factor for survival and radical surgery should be contemplated in all cases of locoregionally limited thymoma.

A Phase II Trial of FM (Oral Fludarabine and Mitoxantrone) Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®) for Previously Untreated Follicular Lymphoma (FL) Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2479-2479 ◽  
Author(s):  
Pier Luigi Zinzani ◽  
Alessandro Pulsoni ◽  
Manuela Balocco ◽  
Monica Tani ◽  
Stefano Fanti ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Safety Data ◽  
Stage Iv ◽  
Bone Marrow Examination ◽  
Stage Ii ◽  
Efficacy And Safety ◽  
Ibritumomab Tiuxetan ◽  
Open Label ◽  
Grade 3

Abstract We conducted a prospective, multicenter, single-arm, open-label, non-randomized, phase II study to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a new approach combining induction chemotherapy with oral Fludarabine and Mitoxantrone (FM) followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated FL. Patient eligibility was represented by: age ≥ 18 years with biopsy-proven, untreated; stage II – IV FL grade I–II; WHO performance status of 0 to 2. All patients signed a written informed consent. Patients were treated with standard FM chemotherapy (Fludarabine was administered orally at the dose 40 mg/m2/day for 3 consecutive days) every 28 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of FM. Patients achieving at least a PR after 6 cycles of FM chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was > 1500/μL, the platelet count >100.000/μL, lymphocytes expressing the CD20 antigen and the bone marrow examination at the completion of FM demonstrated < 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). At data reporting for this abstract, 62 patients were enrolled and 41 were evaluable for response. Of these 41 patients, all are evaluable for induction FM regimen and 19 of them also are evaluable after 90Y Ibritumomab Tiuxetan treatment. 15 were male and 26 female; the median age was 52.5 years (range 36–70); 5 were stage II, 12 stage III, and 24 stage IV. After the FM treatment the OR rate was 100%, including 73% complete remissions (CR + CRu) and 27% PR. Time to event analyses, including TTP and duration of response are pending further follow-up. Treatment was well tolerated; grade ≥ 3 AEs were seen in 20 patients; the most common grade ≥ 3 AEs was neutropenia. Among the actual 19 evaluable patients subsequentially treated with 90Y Ibritumomab Tiuxetan, 3/5 (60%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 12 patients. These preliminary data indicate: 1) FM regimen including oral fludarabine presents the same activity of i.v. formulation one without significant gastrointestinal toxicity and with a better patient compliance; 2) feasibility, tolerability, and efficacy of the FM plus 90Y Ibritumomab Tiuxetan regimen for untreated FL. Final efficacy and safety data will be presented.

Single-agent pemetrexed in patients with advanced and metastatic hepatoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14064-14064
Author(s):  
A. Cohn ◽  
J. W. Myers ◽  
S. Mamus ◽  
C. Deur ◽  
S. Nicol ◽  
...  
Keyword(s):  
Liver Failure ◽  
Histological Grade ◽  
Hepatoma Cell ◽  
Single Agent ◽  
Stage Iv ◽  
The United States ◽  
Toxicity Profile ◽  
Hepatoma Cell Lines ◽  
Grade 3 ◽  
Ecog Ps

14064 Background: The incidence of hepatoma is rising in the United States, primarily due to the increase in the prevalence of hepatitis C. Surgical treatments are rarely an option for patients with advanced hepatoma, and while chemotherapy, particularly with doxorubicin-based regimens, has marginally prolonged survival, response rates have been poor with the burden of high toxicity. Pemetrexed, a folate antimetabolite, has demonstrated activity in hepatoma cell lines with a manageable toxicity profile, making it a potentially useful agent in hepatocellular carcinoma. Methods: A multicenter, Phase II study was conducted to assess the response rate and evaluate the toxicity profile of single-agent pemetrexed (ALIMTA) in first-line patients with advanced or metastatic hepatoma. Pemetrexed 600 mg/m2 IV was administered on Day 1 of each 21-day cycle until disease progression (PD). Patients were premedicated with dexamethasone 4 mg PO BID and received daily folic acid 350–1000 μg PO and Vitamin B12 1000 μg IM every 9 weeks. Results: This nonrandomized study employed Simon’s 2-stage design. There were 21 eligible patients enrolled in the first stage, and all 21 patients were enrolled within 4 months of trial opening. Median age was 72 years (range, 44–88), and most patients were white (62%) and male (81%). Ten percent (10%) had an ECOG PS of 2, 48% Stage IV disease, 52% prior surgery, and 33% tumors of unknown histological grade. The plan was to stop accrual if ≤2 responders were observed among the 21 patients. Of the 21 patients, 3 had SD, 2 had early toxicities (renal/liver failure, sepsis), 15 progressed, and 1 was noncompliant. The trial was closed due to lack of response. The most common Grade 3 hematological toxicities were neutropenia 6/21 (28.6%) and thrombocytopenia 3/21 (14.3%). One patient experienced both Grade 3 nausea and vomiting. There were no Grade 4 toxicities. There were 10 on-study deaths: 9 PD and 1 liver failure. None of the deaths were drug-related. The median actual survival was 2.5 months (range, <1–8). Conclusions: While pemetrexed was well tolerated in this patient population, it was not active. Most adverse events were related to disease state, not study treatment. Supported by Eli Lilly and Company, Indianapolis, IN [Table: see text]

Correlation, comparison, and combined analysis of Ki-67 and histological grade for early luminal breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 585-585 ◽  
Author(s):  
Yoichi Naito ◽  
Satoshi Fujii ◽  
Kuniaki Itoh ◽  
Masahiko Nezu ◽  
Nobuaki Matsubara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Histological Grade ◽  
Luminal Breast Cancer ◽  
Prognostic Impact ◽  
Ki 67 ◽  
Combined Analysis ◽  
Combination Methods ◽  
Grade 3 ◽  
Worse Prognosis

585 Background: Both Ki-67 and histological grade are established prognostic factors in patients with early breast cancer. Recent international expert consensus employs Ki-67 to classify luminal breast cancer, and histological grade is described as an alternative. We investigated the prognostic value of Ki-67, histological grade, and their combination. Methods: Patients with early breast cancer treated with surgery between January 2000 and December 2008 were retrospectively reviewed. Inclusion criteria were as follows: estrogen receptor positive, HER2 negative, available for Ki-67 and histological grade. Clinicopathological data were retrieved from medical records. Ki-67 labeling index was investigated using MIB-1 antibody and subdivided into three categories: low 0-9%; intermediate 10-19%; high >20%. Histological grade was scored between 1 and 3. Disease-free survival (DFS) was defined as time from surgery to the first documented disease recurrence or death. Ki-67 categories and histological grade were analyzed respectively and then concomitantly for prognostic impact on DFS. Results: A total of 606 patients were included. Median age was 58 and 28.1% were over 65 years. 65.4% were postmenopausal women. Progesterone receptor was positive in 84.0% of patients. 29.6% received neoadjuvant or adjuvant chemotherapy. Number of lymph node metastasis was 0 in 70.0%, 1-3 in 21.3%, and >4 in 8.7% of patients. Ki-67 categories and histological grade showed weak but significantly correlation (Spearman’s rho = 0.385, p<0.001). High Ki-67 and histological grade 3 were correlated with worse prognosis to the same extent (HR 2.518, p = 0.002 and HR 2.541, p = 0.048, respectively). For combined analysis, patients represented concomitant with high Ki-67 and histological grade 3 showed worse prognosis compared with those with Ki-67 low and histological grade 1 (HR 3.137, p = 0.021). Conclusions: Ki-67 and histological grade were significantly but weakly correlated. Combined use of these two factors could better predict recurrence of early luminal breast cancer.

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