Prognosis and patterns of failure after curative pancreaticoduodenectomy for early-stage ampullary adenocarcinomas.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14728-e14728
Author(s):  
Adriana Regina G. Ribeiro ◽  
Milton Jose B Silva ◽  
Wilson Luiz Costa ◽  
Joyce Maria L. Maia ◽  
Fernando Vidigal Padua ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Lymph Nodes ◽  
Relapse Rate ◽  
Distant Metastasis ◽  
Early Stage ◽  
Disease Free Survival ◽  
Local Relapse ◽  
Lymph Node Status ◽  
R0 Resection ◽  
Free Survival

e14728 Background: Ampullary cancer (AC) is a rare malignancy. There is no consensus about the role of adjuvant radiotherapy and chemotherapy, mainly for early-stage tumors. Methods: Between 2007 and 2012 we performed a retrospective analysis of patients with AC that underwent a pancreaticoduodenectomy (PD) with curative intent in our institution. Results: Twenty-four patients underwent (PD), (M:F=13:11), median age was 63 (range35-83), 87% had R0 resection, median of resected lymph-nodes was 8.5 (range 2-30), 29% had positive lymph-nodes, 46% had perineural invasion, 21% had vascular invasion, 29% had lymphatic invasion, 50% had tumors > 2 cm, 54% had moderately differentiated tumors. AJCC stage pathologic grouping was: I=37,5%, II=29%, III=33%; Median follow-up was 27 months, median progression free survival was 29 months and median overall survival was 101 months. Only lymph-node status was independent prognostic factor for disease free survival on multivariate analysis (p=0,045, HR: 7,8). Among patients with early-stage tumors (n=13), only one received adjuvant therapy. The relapse rate was 23% and 50%, for stage I and IIa tumors, respectively. Among the recurrences, 80% of relapses were distant metastasis without local relapse. In patients with stage IIb and III tumors (n=11), 63,6% received adjuvant treatment (57% chemotherapy and 43% radiochemotherapy). The relapse rate was 100% and 75%, respectively, and 66% of these relapses were distant metastasis without local relapse. 75% of patients who had local recurrence had tumors in stage IIb or III. Conclusions: Our study shows a high disease relapse rate in well-operated patients, even in early-stage tumors, with no nodal involvement, mainly with distant disease. The majority of patients who had local relapses had a more advanced stage and systemic relapses associated. This information can help guide decisions on the choice of adjuvant therapy.

Metastasectomy in colorectal carcinoma (CRC) patients (pts) with mBRAF: Prospective database analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15549-e15549
Author(s):  
Mikhail Fedyanin ◽  
Kheda Elsnukaeva ◽  
Irina Demidova ◽  
Daniil Stroyakovskiy ◽  
Yuri Shelygin ◽  
...  
Keyword(s):  
Lymph Nodes ◽  
Lung Resection ◽  
Disease Free Survival ◽  
Local Relapse ◽  
R0 Resection ◽  
Mutational Status ◽  
Primary Endpoints ◽  
Lymph Nodes Dissection ◽  
Practice Methods

e15549 Background: Role of metastasectomy in pts with mBRAF metastatic CRC is still controversial. We performed analysis of prospective multicentric database of pts with mBRAF mCRC to evaluate the efficacy of metastasectomy in such group of pts in the real clinical practice. Methods: We analyzed a database of pts with mCRC in 7 cancer clinics in Russia and chose pts with metastasectomy with different mutational status. The primary endpoints were disease free survival (DFS) and overall survival (OS), which were calculated from the time of metastasectomy. Analysis was performed with the SPSS v.20 software package. Results: The study included 126 pts: 26 pts with mBRAF, 57 pts with mRAS and 43 pts with wtRAS/BRAF. Pts with mBRAF more often had synchronous metastases (50%/19,3/11,6%, p<0,01), N2 status (38,5%/11%/19,6%, p=0,04). In mBRAF cohort all but 1 pt had V600 mutations; peritonectomy performed in 19,2%, liver resection – in 34,6%, lung resection, ovariectomy, metastasectomy in brain and retroperitoneal lymph nodes dissection with removal of the local relapse – over 11,5%; R0 resection was achieved in 88,5%. Median DFS was 7 months in mBRAF pts, 14 months in mRAS and not achieved in wtRAS/BRAF group treated (HR 2,1, 95%CI 1,5-3.1, p<0.01). Median OS was 26 months in mBRAF, 38 months in mRAS and not achieved in wtRAS/BRAF group (HR 1,5, 95%CI 1,0-2,4, p=0.06). Perioperative chemotherapy didn’t improve DFS in pts with mBRAF (HR 1,9, 95%CI 0,67-5,7, p=0,2). The best median DFS were in pts after ovariectomy – 10 months, the worst - after retroperitoneal lymph nodes dissection with removal of the local relapse – 2 months. Conclusions: Prognosis of pts with mBRAF after metastasectomy is worse than with other mutational phenotypes. However in selected cases metastasectomy might be considered in such aggressive mCRC.

scholarly journals Should the Number of Metastatic Pelvic Lymph Nodes Be Integrated into the 2018 Figo Staging Classification of Early Stage Cervical Cancer?

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1552
Author(s):  
Luigi Pedone Anchora ◽  
Vittoria Carbone ◽  
Valerio Gallotta ◽  
Francesco Fanfani ◽  
Francesco Cosentino ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Nodes ◽  
Early Stage ◽  
Disease Free Survival ◽  
Staging System ◽  
Lymph Node Status ◽  
P Value ◽  
Pelvic Lymph Nodes ◽  
Early Stage Cervical Cancer ◽  
The Impact

Introduction: Lymph node status has become part of the new staging system for cervical cancer (CC). It has been shown that patients staged as IIIC1 had heterogeneous prognoses and, in some cases, experienced better outcomes than patients with lower stages. We evaluated the impact of the number of metastatic pelvic lymph nodes (MPLNs) among patients with stage IIIC1 cervical cancer. Methods: Survival analyses were conducted in order to identify the best cut-off prognostic value relative to the number of MPLNs. Disease free survival (DFS) was considered the main outcome. Results: 541 patients were included in the study. Eighty-nine patients were of stage IIIC1. The best prognostic cut-off value of the number of MPLNs was 2. Patients with >2 MPLNs (n > 2 group) had worse DFS compared with those having <2 (N1-2 group) (5 yr DFS: 54.7% vs. 78.1%, p value = 0.006). Multivariate analyses demonstrated that the extent of MPLNs had little impact on DFS and that replacement of IIIC1 staging with N1-2 and n > 2 grouping provided a better, statistically significant model (p value = 0.006). Discussion: Using a cut-off value of 2, the number of MPLNs could better predict prognostic outcomes within stage IIIC1 cervical cancer and have potential implications for therapeutic decision-making in the treatment of patients with stage IIIC1 CC.

Role of adjuvant therapy after R0 resection for patients with distal cholangiocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 355-355
Author(s):  
Young Saing Kim ◽  
In Gyu Hwang ◽  
Song-ee Park ◽  
Eun Young Kim ◽  
Jung Hun Kang ◽  
...  
Keyword(s):  
Lymph Node ◽  
Adjuvant Therapy ◽  
Lymph Nodes ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards Model ◽  
Lymph Node Status ◽  
R0 Resection ◽  
Distal Cholangiocarcinoma ◽  
Positive Lymph Nodes

355 Background: There is still debated regarding the optimal treatment strategy in cholangiocarcinoma after curative resection. The aim of this study was to analyze the role of adjuvant therapy in R0-resected distal cholangiocarcinoma. Methods: We retrospectively reviewed the medical records of patients who underwent R0 resection for distal cholangiocarcinoma between January 2001 and December 2013 at six cancer centers in Korea. Adjuvant therapy consisted of chemotherapy (CT), chemoradiotherapy (CRT), or radiotherapy (RT). Multivariable Cox proportional hazards model was used to identify prognostic factors for overall survival (OS). Results: A total of 158 patients were included in the analysis; 47 patients (29.7%) had lymph node involvement. Fifty-six patients (35.4%) received adjuvant therapy (CT/CRT/RT: 27/20/9, respectively). Patients with advanced TNM stage (p = 0.001), T3/T4 disease (p = 0.009), positive lymph nodes (p = 0.052) and elevated CA 19-9 (p = 0.071) were more likely to receive adjuvant therapy. The effect of adjuvant therapy varied according to the treatment modality. Multivariable analysis showed a significant improvement in OS with CRT (Hazard ratio (HR) 0.25, 95% CI 0.08-0.83, p = 0.024) and CT (HR 0.21, 95% CI 0.08-0.53, p = 0.001). However, RT alone was associated with shorter OS (HR 2.38, p = 0.040), along with T3/T4 disease (HR 2.12, p = 0.012) and positive lymph nodes (HR 2.30, p = 0.008). In the subset analysis according to lymph node status, adjuvant therapy not including RT alone was associated with a significant OS advantage both in node-negative patients (median, 103.3 vs. 54.9 months, p = 0.037) and node-positive patients (not reached vs. 22.6 months, p = 0.013). Conclusions: Our results showed that patients receiving adjuvant CT or CRT had significant improvement in OS. In addition, the benefit of adjuvant therapy (except RT alone) was observed even in patients with negative lymph nodes.

Multicenter randomized controlled phase III study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6095-TPS6095
Author(s):  
Chia-Jung Busch ◽  
Adrian Muenscher ◽  
Christian Stephan Betz ◽  
Volkan Dogan ◽  
Philippe Schafhausen ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Distant Metastasis ◽  
Tumor Antigens ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Late Toxicity ◽  
Standard Of Care ◽  
Phase Iii ◽  
Free Survival ◽  
Treatment Naïve

TPS6095 Background: Surgically treated locally advanced head and neck squamous cell carcinoma (LA HNSCC) often requires postoperative chemoradiation with high risk of acute and late toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining Nivolumab (N), a PD-1inhibitor, and Ipilimumab, a CTLA4 inhibitor, as maintenance therapy may improve DFS due to anti-tumor effects of immunotherapy by enhancing cross-presentation of tumor antigens. The IMSTAR HN study compares neoadjuvant N and N±I 6 months after adjuvant therapy vs the standard therapy as first-line treatment for LA HNSCC. Methods: Eligible pts are ≥18 years old with treatment-naive LA HNSCC (oral cavity, oropharynx p16-, hypopharynx, and larynx), ECOG PS ≤1, and no distant metastasis. 276 pts will be randomized (2:1) into 2 arms and approximately 10 centers in Germany will be involved. Standard of care (arm II) consists of surgical resection followed by risk-adapted adjuvant (chemo)radiation. The experimental arm I receives neoadjuvant N 3mg/kg. After treatment according to standard arm a second randomization will be performed: In arm Ia N 3mg/kg will be given every 2 weeks until progression or up to 6 months. In arm Ib I 1mg/kg will be applied additionally every 6 weeks also until progression or up to 6 months. Primary endpoints is DFS in arms I and II. Secondary endpoints: Local regional control (LRC), distant metastasis free survival (DMFS), overall survival (OS), quality of life (QoL), survival depending on PD-L1 status, comparison of arm Ia vs arm II and Ib vs. II. AEs, graded per CTCAE v4.03, are evaluated for at least 12 months after randomization. The translational program includes investigations concerning immunmodulation, mutational load in general, but also specific mutations in targets involved in immune function and antigen presentation. Recruitment started in August 2018. Clinical trial information: NCT03700905.

Two-year follow-up of single PD-1 blockade in neoadjuvant resectable NSCLC.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8522-8522
Author(s):  
Shugeng Gao ◽  
Ning Li ◽  
Shunyu Gao ◽  
Qi Xue ◽  
Shuhang Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Early Stage ◽  
Disease Free Survival ◽  
Postoperative Treatment ◽  
R0 Resection ◽  
Free Survival ◽  
Treatment Naïve

8522 Background: Early stage non-small-cell lung cancer (NSCLC) could benefit from anti-programmed cell death-1 (PD-1) monotherapy; however, the survival profiles remain to be disclosed. Here, we presented the two-year follow-up outcomes from a phase 1b study of sintilimab, an anti-PD-1 inhibitor in the neoadjuvant setting of NSCLC. Methods: Treatment-naive pts with resectable NSCLC (stage IA–IIIB) received two cycles of sintilimab followed by surgical resection. Postoperative treatment of sintilimab was at the discretion of investigator. The primary endpoint was AE, and key secondary endpoints included major pathological response (MPR), disease free survival (DFS) rate of 1 year and 2 years, and overall survival (OS) rate of 2 years. Results: Among 40 enrolled pts, 36 (90%) underwent R0 resection and were included in the R0 resection population. By data cutoff (January 20, 2021), the median follow-up for DFS and OS for all the enrolled pts was 23.9 (IQR 20.5–24.4) months and 26.4 (IQR 24.2–29.0) months. A total of 12 (33.3%) pts experienced relapse, and 6 pts died. The 1-yr and 2-yr DFS rate was 91.7%/73.3%. The 2-yr OS rate for overall population and R0 population was 87.5%/91.7%, respectively. In the R0 resection population, the median DFS and OS were both not reached. Superior 2-year DFS rates were observed in pts who achieved MPR (MPR vs. Non-MPR: 86.7% vs. 63.8%). DFS of pts with non-squamous cell carcinoma tended to be shorter than that of pts with squamous cell carcinoma (HR 2.71 [95%CI 0.67–11.0], p=0.1479). Pts with tumor mutation burden (TMB) ≥10 mutations/Mb and PD-L1 tumor proportion score (TPS)≥50% tended to have a better 2-yr DFS rate compared to those with TMB<10 and TPS<50. [table] For the post-hoc event free survival (EFS) analysis, the same trend was observed with DFS among different subgroups, and patients with TMB ≥10 mutations/Mb had a significant improved EFS (HR 0.125[95% CI 0.02,1.03], P=0.0222). Conclusions: Anti-PD-1 monotherapy emerged to be a promising neoadjuvant therapeutic strategy for resectable NSCLC with improved clinical outcomes. MPR could serve as a surrogate efficacy biomarker in this setting. Clinical trial information: ChiCTR-OIC-17013726. [Table: see text]

scholarly journals Disease-free Survival of Patients with Differentiated Thyroid Cancer: A Study from a Tertiary Center in Oman

2021 ◽  
Vol 36 (2) ◽  
pp. e246-e246
Author(s):  
Fathimabeebi P. Kunjumohamed ◽  
Abdulhakeem Al Rawahi ◽  
Noor B. Al Busaidi ◽  
Hilal N. Al Musalhi
Keyword(s):  
Thyroid Cancer ◽  
Prognostic Factors ◽  
Lymph Node ◽  
Distant Metastasis ◽  
Differentiated Thyroid Cancer ◽  
Disease Free Survival ◽  
Lymph Node Status ◽  
Free Survival ◽  
Disease Free

Objectives: As with global trends, the prevalence of differentiated thyroid cancer (DTC) has increased in recent years in Oman. However, to the best of our knowledge, no local studies have yet been published evaluating the prognosis of DTC cases in Oman. This study aimed to assess disease-free survival (DFS) and prognostic factors related to DTC among Omani patients attending a tertiary care center. Methods: This retrospective, observational cohort study was conducted between January 2006 and May 2016 at the National Diabetes and Endocrine Center in Oman. Data related to DFS and prognostic factors were obtained from the electronic medical records of all ≥ 18-year-old patients diagnosed with DTC during the study period. Results: A total of 346 DTC cases were identified. Overall, 82.7% of patients were disease-free at their last follow-up appointment. Univariate analysis indicated that various tumor characteristics including histological subtype (i.e., papillary carcinoma, Hurthle cell cancer, and minimally invasive follicular thyroid carcinoma), lymph node status, number of lymph node metastases, distant metastasis status, and TNM status (primary tumor (T), regional lymph node (N), distant metastasis (M) stage) were strong prognostic factors for DFS (p < 0.050). According to multivariate regression analysis, lymph node status, extrathyroidal extension, and angiovascular invasion were independent predictors of DFS (p < 0.050). Conclusions: The overall prognosis of DTC among Omani patients was excellent. Treatment and follow-up strategies for patients with DTC should be tailored based on the individual’s risk factor profile.

scholarly journals Consolidation chemotherapy in early-stage cervical cancer patients with lymph node metastasis after radical hysterectomy

2020 ◽  
Vol 30 (5) ◽  
pp. 602-606 ◽  
Author(s):  
Mei Ling Zhong ◽  
Ya Nan Wang ◽  
Mei Rong Liang ◽  
Hui Liu ◽  
Si Yuan Zeng
Keyword(s):  
Overall Survival ◽  
Lymph Nodes ◽  
Concurrent Chemoradiotherapy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Consolidation Chemotherapy ◽  
Free Survival ◽  
Early Stage Cervical Cancer ◽  
Disease Free ◽  
Positive Lymph Nodes

ObjectivePost-operative concurrent chemoradiotherapy has become the standard treatment for patients with positive lymph nodes after radical surgery. The aim of this study was to explore the efficiency and safety of consolidation chemotherapy in early-stage cervical cancer patients with lymph node metastasis after radical hysterectomy.MethodWe reviewed the medical records of patients with early-stage cervical cancer with lymph node metastasis after radical hysterectomy from January 2010 to January 2017. All patients underwent adjuvant concurrent chemoradiotherapy (n=49) or three cycles of platinum-based consolidation chemotherapy following concurrent chemoradiotherapy (n=89). The primary end points of the study were disease-free survival and overall survival.ResultsThe median follow-up time was 51 months (range 10–109). No significant difference was noted in disease-free survival, overall survival, or grade 3/4 gastrointestinal disorder between the consolidation chemotherapy group (78.1% vs 83.1% vs 6.7%) and the concurrent chemoradiotherapy alone group (75.4% vs 75.3% vs 4.1%), (p=0.42, 0.26, 0.80, respectively). However, the grade 3/4 myelosuppression rate in the consolidation group was higher than in the concurrent chemoradiotherapy alone group (40.4% vs 22.4%, p=0.03). For patients with >3 positive lymph nodes or patients with >2 positive lymph nodes+lymphovascular space invasion/≥1/3 stromal invasion, disease-free survival and overall survival were superior in the consolidation chemotherapy group compared with the concurrent chemoradiotherapy alone group (p<0.05).ConclusionIn patients with >3 positive lymph nodes or patients with >2 positive lymph nodes, lymphovascular space invasion, and greater than 1/3 stromal invasion, disease-free survival and overall survival were superior with consolidation chemotherapy. However, consolidation chemotherapy was also associated with an increased grade 3/4 myelosuppression rate.

Efficacy of Oral Adjuvant Therapy After Resection of Colorectal Cancer: 5-Year Results From Three Randomized Trials

2004 ◽  
Vol 22 (3) ◽  
pp. 484-492 ◽  
Author(s):  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Therapy ◽  
Oral Therapy ◽  
Randomized Trials ◽  
Early Stage ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Free Survival ◽  
Oral Fluoropyrimidines ◽  
Disease Free

Purpose Adjuvant therapy of colorectal cancer with oral fluorinated pyrimidines is attractive because of its ease of administration and good tolerability. The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year. Patients and Methods This meta-analysis was performed on individual data from three randomized trials conducted by the Japanese Foundation for Multidisciplinary Treatment for Cancer involving a total of 5,233 patients with stages I to III colorectal cancer. Results The overall hazard ratio in favor of oral therapy was 0.89 for survival (95% CI, 0.80 to 0.99; P = .04), and 0.85 for disease-free survival (95% CI, 0.77 to 0.93; P < .001). Thus oral therapy reduced the risk of death by 11% and the risk of recurrence or death by 15%. There was no significant heterogeneity between trials, nor did the benefit of oral therapy depend on tumor stage (I, II, or III), tumor site (rectum or colon), patient age, or patient sex. Conclusion Oral fluoropyrimidines improve disease-free survival and survival of patients after resection of early-stage colorectal cancer. These observations support the use of these agents alone after resection of early-stage disease, as well as further testing of oral agents in combination with new drugs that have recently shown antitumor activity in advanced colorectal cancer.

scholarly journals A phase III study of atezolizumab (atezo) vs placebo as adjuvant therapy in renal cell carcinoma (RCC) patients (pts) at high risk of recurrence following resection (IMmotion010).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4598-TPS4598 ◽  
Author(s):  
Robert Uzzo ◽  
Axel Bex ◽  
Brian I. Rini ◽  
Laurence Albiges ◽  
Cristina Suarez ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Distant Metastasis ◽  
Single Agent ◽  
Tumor Resection ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Disease Stage ◽  
Free Survival ◽  
Risk Of Recurrence

TPS4598 Background: Nephrectomy is the SOC in early RCC; however, the 5-y relapse rate is 30-40% in stage II or III pts, with tumor stage and grade correlating with survival and recurrence after surgery. Currently, there is a limited role for adjuvant therapy after nephrectomy in pts who have had complete tumor resection; observation is standard. In a Ph II first-line metastatic RCC study, treatment with single-agent atezo (anti–PD-L1) resulted in an ORR of 25%. Thus, IMmotion010, a Ph III, multicenter, randomized, placebo-controlled, double-blinded trial, will evaluate the efficacy and safety of atezo as adjuvant therapy in RCC pts who are at high risk of recurrence after resection (NCT03024996). Methods: Eligible RCC pts (clear cell or sarcomatoid histologies) will have undergone nephrectomy (radical or partial) and be at high risk of recurrence (T2 Grade 4, T3a Grade 3-4, T3b/c any Grade, T4 any Grade or TxN+ any Grade) or have had complete resection of limited metachronous/synchronous metastasis. Pts must show no residual disease or evidence of metastases by CT scan at enrollment. ECOG PS ≤ 1 and tumor specimens evaluable for PD-L1 will also be required. Pts will be randomized 1:1 to receive atezo 1200 mg IV q3w or placebo IV q3w for 16 cycles or 1 y; stratification will be by disease stage (T2/T3a vs T3b/c/T4/N+ vs metastasectomy), region (North America [excluding Mexico] vs rest of world) and PD-L1 status on tumor-infiltrating immune cells (IC; PD-L1 IC expression < 1% vs ≥ 1%). The primary endpoint is independent review facility (IRF)-assessed disease-free survival (DFS), defined as the time from randomization to the first documented recurrence event (local recurrence, new primary RCC, distant metastasis) or death. Secondary endpoints include OS, investigator-assessed DFS, IRF-assessed and investigator-assessed DFS in pts with ≥ 1% PD-L1 IC, disease-specific survival, distant metastasis-free survival and the 3-y rates of IRF-assessed DFS and investigator-assessed DFS. Safety and biomarkers will be evaluated. The planned analysis will occur when at least ≈ 65% of pts in the 2 populations have died. 664 pts will be enrolled at 150-200 sites worldwide. Clinical trial information: NCT03024996.

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