scholarly journals Chemoradiotherapy Using Carboplatin plus Paclitaxel versus Cisplatin plus Fluorouracil for Esophageal or Gastroesophageal Junction Cancer

Oncology ◽  
2020 ◽  
Vol 99 (1) ◽  
pp. 49-56
Author(s):  
Di Maria Jiang ◽  
Hao-Wen Sim ◽  
Osvaldo Espin-Garcia ◽  
Bryan A. Chan ◽  
Akina Natori ◽  
...  
Keyword(s):  
Cox Regression ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Sensitivity Analyses ◽  
Trimodality Therapy ◽  
Gastroesophageal Junction Cancer ◽  
Kaplan Meier

<b><i>Background:</i></b> Trimodality therapy (TMT) with neoadjuvant chemoradiotherapy (nCRT) using concurrent carboplatin plus paclitaxel (CP) followed by surgery is the standard of care for locoregional esophageal or gastroesophageal junction (GEJ) cancers. Alternatively, nCRT with cisplatin plus fluorouracil (CF) can be used. Definitive chemoradiotherapy (dCRT) with CP or CF can be used if surgery is not planned. In the absence of comparative trials, we aimed to evaluate outcomes of CP and CF in the settings of TMT and dCRT. <b><i>Methods:</i></b> A single-site, retrospective cohort study was conducted at the Princess Margaret Cancer Centre to identify all patients who received CRT for locoregional esophageal or GEJ cancer. Overall survival (OS) and disease-free survival (DFS) were assessed using the Kaplan-Meier method and multivariable Cox regression model. The inverse probability treatment weighting (IPTW) method was used for sensitivity analysis. <b><i>Results:</i></b> Between 2011 and 2015, 93 patients with esophageal (49%) and GEJ (51%) cancers underwent nCRT (<i>n</i> = 67; 72%) or dCRT (<i>n</i> = 26; 28%). Median age was 62.3 years and 74% were male. Median follow-up was 23.9 months. Comparing CP to CF in the setting of TMT, the OS and DFS rates were similar. In the setting of dCRT, CP was associated with significantly inferior 3-year OS (36 vs. 63%; <i>p</i> = 0.001; HR 3.1; 95% CI: 1.2–7.7) and DFS (0 vs. 41%; <i>p</i> = 0.004; HR 3.6; 95% CI: 1.4–8.9) on multivariable and IPTW sensitivity analyses. <b><i>Conclusions:</i></b> TMT with CF and CP produced comparable outcomes. However, for dCRT, CF may be a superior regimen.

Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4003-4003
Author(s):  
Ronan Joseph Kelly ◽  
Jaffer A. Ajani ◽  
Jaroslaw Kuzdzal ◽  
Thomas Zander ◽  
Eric Van Cutsem ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Distant Recurrence ◽  
Meaningful Improvement ◽  
Free Survival ◽  
Gastroesophageal Junction Cancer

4003 Background: In CheckMate 577 (NCT02743494), NIVO demonstrated a significant and clinically meaningful improvement in disease-free survival (DFS; primary endpoint) vs placebo (PBO) and was well tolerated in patients (pts) with resected (R0) stage II/III EC/GEJC who received neoadjuvant CRT and had residual pathologic disease. Median DFS doubled with NIVO vs PBO (22.4 vs 11.0 months; HR 0.69; 96.4% CI 0.56–0.86; P = 0.0003). Serious treatment-related adverse events (TRAEs) and TRAEs leading to discontinuation were reported for < 10% of pts with NIVO and 3% with PBO. Methods: Pts were randomized 2:1 to NIVO 240 mg or PBO Q2W for 16 weeks, followed by NIVO 480 mg or PBO Q4W. Here, we present additional efficacy, safety, and quality-of-life (QoL) data from CheckMate 577. Results: 794 pts were randomized (NIVO, 532; PBO, 262). Distant recurrence was reported for 29% vs 39% and locoregional recurrence for 12% vs 17% of pts in the NIVO vs PBO groups, respectively. Median distant metastasis-free survival was 28.3 vs 17.6 months with NIVO vs PBO (HR 0.74; 95% CI 0.60–0.92). Median progression-free survival 2 (PFS2; time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death, whichever is earlier) was not reached with NIVO vs 32.1 months with PBO (HR 0.77; 95% CI 0.60–0.99). TRAEs with potential immunologic etiology (select TRAEs; sTRAEs) reported for NIVO are presented in the table. Results for the FACT-ECS and FACT-G7 showed similar trends for QoL improvement from baseline for NIVO and PBO during treatment and maintained benefit post-treatment. Conclusions: Adjuvant NIVO demonstrated clinically meaningful efficacy, an acceptable safety profile, and maintained QoL, providing further support for its use as a new standard of care for pts with resected EC/GEJC who received neoadjuvant CRT with residual pathologic disease. Clinical trial information: NCT02743494. [Table: see text]

Pituitary surgery as alternative to dopamine agonists treatment for microprolactinomas, a cohort study

2021 ◽  
Author(s):  
Bertrand Baussart ◽  
Chiara Villa ◽  
Anne Jouinot ◽  
Marie-Laure Raffin-Sanson ◽  
Luc Foubert ◽  
...  
Keyword(s):  
Dopamine Agonists ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Pituitary Surgery ◽  
Cerebrospinal Fluid Leakage ◽  
Neurosurgical Department ◽  
Free Survival ◽  
Kaplan Meier ◽  
Disease Free

Objective: Microprolactinomas are currently treated with dopamine agonists. Outcome information on microprolactinoma patients treated by surgery is limited. This study reports the first large series of consecutive non-invasive microprolactinoma patients treated by pituitary surgery and evaluates the efficiency and safety of this treatment. Design: Follow-up of a cohort of consecutive patients treated by surgery. Methods: Between January 2008 and October 2020, 114 adult patients with pure microprolactinomas were operated on in a single tertiary expert neurosurgical department, using an endoscopic endonasal transsphenoidal approach. Eligible patients were presenting a microprolactinoma with no obvious cavernous invasion on MRI. Prolactin was assayed before and after surgery. Disease-free survival was modeled using Kaplan-Meier representation. A cox regression model was used to predict remission. Results: Median follow-up was 18.2 months (range: 2.8 to 155). In this cohort, 14/114 (12%) patients were not cured by surgery, including 10 early surgical failures, and 4 late relapses occurring 37.4 months (33 to 41.8) after surgery. From Kaplan Meier estimates, 1-year and 5-year disease free survival were 90.9% (95% CI, 85.6%-96.4%) and 81% (95% CI,71.2%-92.1%) respectively. The preoperative prolactinemia was the only significant preoperative predictive factor for remission (P<0.05). No severe complication was reported, with no anterior pituitary deficiency after surgery, one diabetes insipidus, and one postoperative cerebrospinal fluid leakage properly treated by muscle plasty. Conclusions: In well selected microprolactinoma patients, pituitary surgery performed by an expert neurosurgical team is a valid first-line alternative treatment to dopamine agonists.

Comparison of bimodality versus trimodality therapy for esophageal or gastroesophageal junction (GEJ) cancer: Experience from the Princess Margaret Cancer Centre.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 122-122
Author(s):  
Akina Natori ◽  
Hao-Wen Sim ◽  
Bryan Anthony Chan ◽  
Peiran Sun ◽  
Stephanie Moignard ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Gastroesophageal Junction ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Curative Intent ◽  
Trimodality Therapy ◽  
Treatment Algorithms ◽  
Multivariable Regression ◽  
Cancer Experience

122 Background: There are no phase 3 trials comparing definitive chemoradiation (bimodality) versus. perioperative chemoradiation (trimodality) for locoregional esophageal/GEJ cancer. Methods: A retrospective analysis (2011-2015) compared bimodality and trimodality therapy in patients (pts) with locoregional esophageal/GEJ cancer treated with curative intent. Overall survival (OS) and disease-free survival (DFS) were calculated from the date of diagnosis. Uni- and multivariable Cox proportional hazards regression adjusted for patient and disease factors. Results: Of 108 patients, 82 (76%) were male. Mean ages were 69.5 ± 11.0 years (bimodality; N = 41) and 60.5 ± 11.1 years (trimodality; N = 67). For bimodality pts, 37% had adenocarcinoma and 63% had squamous cell carcinoma (SCC). For trimodality pts, 79% had adenocarcinoma and 21% had SCC (p < 0.0001). Bimodality pts received a higher radiation dose compared to trimodality pts (50.1 ± 6.7 vs. 45.2 ± 6.4 Gy). Median follow-up was 49.3 months. We found no significant OS difference between bimodality (27.0 months) and trimodality therapy (29.8 months) in the overall cohort (p = 0.57) (4 year OS rate: 42% vs. 38%). In the subgroup with adenocarcinoma histology, trimodality therapy significantly improved OS and DFS compared to bimodality (OS: 31.8 vs. 10.4 months, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.18-0.66, p = 0.001; DFS: 15.0 vs. 6.7 months; HR 0.39, 95%CI 0.21-0.73, p = 0.003). In the SCC subgroup, median OS and DFS were similar (OS: not reached vs. 29.2 months, p = 0.48; DFS: 27.0 vs. 24.0, p = 0.96). Using multivariable regression with AIC backward selection, the only retained prognostic factors were treatment modality (p = 0.06) and histology (p = 0.01). Conclusions: Our findings support preferential use of trimodality therapy for pts with adenocarcinoma histology given superior OS and DFS, whereas bimodality and trimodality therapy appeared comparable in pts with SCC histology. Pending confirmation in a larger series with longer follow-up, these findings suggest differential treatment algorithms for locoregional esophageal and GEJ cancer based on tumor histology.

PET-directed chemoradiation (CRT) with induction FOLFOX compared to induction carboplatin/paclitaxel (CP) in patients with locally advanced esophageal adenocarcinoma (EA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4554-4554
Author(s):  
Rebecca Carr ◽  
Meier Hsu ◽  
Kay See Tan ◽  
Manjit S. Bains ◽  
Matthew Bott ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Complication Rates ◽  
Trimodality Therapy ◽  
Kaplan Meier ◽  
Multivariable Analyses

4554 Background: Induction chemotherapy with PET-directed CRT and surgery is the standard treatment for locally advanced EA at our institution. Following results of the CALGB 80803 trial, FOLFOX has recently replaced CP as the preferred induction regimen. Methods: We retrospectively evaluated patients with locally advanced EA treated with induction CP vs FOLFOX, followed by trimodality therapy between January 2010 and June 2019. Patients treated with CP with RT followed by surgery without induction chemo were also included. We compared pathological complete response (pCR) and near pCR (ypN0 with ≥90% response) rates in the induction FOLFOX group to the induction CP and no-induction groups. Univariable and multivariable analyses were used to adjust for confounding factors. Disease-free survival (DFS) was estimated by the Kaplan-Meier method and compared between groups using max-combo weighted log rank test. Results: 445 patients were included. Patients in the induction FOLFOX group had significantly higher pCR and near pCR rates vs induction CP patients. Notably, pCR rate was 38% among FOLFOX PET responders vs 19% in non-responders. In multivariable analysis, compared to induction CP, induction FOLFOX administration was an independent predictor of near pCR (OR: 2.22, 95%CI: 1.20-4.20, p = 0.012). Compared to 24% pCR rate among no-induction patients, induction FOLFOX pCR rate was slightly higher at 32%. DFS by 2-years was higher in induction FOLFOX compared to no-induction-treated patients (62% vs. 42%, p = 0.05). Postoperative complication rates were similar among the three groups. Conclusions: PET-directed CRT with FOLFOX instead of CP improves pCR and near pCR rates. Improved DFS was observed in the FOLFOX vs no-induction patients. Longer follow-up is needed to confirm any survival benefits. [Table: see text]

Patterns of failure following trimodality therapy for locally advanced esophageal cancer (EC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 88-88
Author(s):  
Jennifer Anne Dorth ◽  
Christopher Willett ◽  
Brian G. Czito
Keyword(s):  
Esophageal Cancer ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Disease Recurrence ◽  
Distal Margin ◽  
Trimodality Therapy ◽  
Distant Failure ◽  
Kaplan Meier ◽  
Nodal Failure

88 Background: Patterns of local-regional failure (LRF) after neoadjuvant chemoradiotherapy (CRT) and surgery for locally-advanced EC are poorly defined. Methods: This study reviewed pts treated with CRT followed by surgery for M0 esophageal cancer from 1995-2009. Staging and regional nodes (supraclavicular (SCV) through celiac) were defined based on AJCC 7th edition. Patterns of first failure were analyzed. LRF included: 1) initially involved nodal failure (INF), 2) initially uninvolved (subclinical) nodal failure (SNF), and/or 3) anastomotic. Abdominal para-aortic failure (PAF) at or below the superior mesenteric artery was scored separately. Isolated SNF or PAF was defined as no other local or distant failure. Actuarial local-regional control (LRC), event-free survival (EFS), and overall survival (OS) were estimated by the Kaplan-Meier method. Results: 156 patients were identified with a median age of 60 years. Primary location was upper in 1%, middle 17%, lower 32% and gastroesophageal junction (GEJ) 50% (Adeno: 79%; SCC: 21%). Staging included EUS (73%), CT (46%), and/or PET/CT (54%). 40% had stage II and 60% stage III disease. Concurrent CRT was primarily cisplatin/taxane and/or 5-FU-based. Primary RT fields (median dose: 45Gy) encompassed the tumor with an approximate 5 cm proximal and distal margin and included standard regional nodes. Boost fields (median total dose: 50.4Gy) encompassed gross disease with a 2 cm margin. Surgical technique was transhiatial (28%), Ivor-Lewis (47%), or tri-incisional (25%) with a median of 8 nodes dissected. Median f/u was 1.3 years. 2-yr LRC, EFS, and OS were 83%, 36%, and 49%. 2-yr SNF was 15% (n=14); anastomotic failure was 7% (n=7). SNFs were SCV (n=5), mediastinal (n=12), and/or celiac (n=3). 95% of SNFs were outside or near the margin of the primary RT fields. 2-yr isolated SNF was 3% (n=3), PAF was 11% (n=9), and isolated PAF 6% (n=5). Conclusions: SNF is the most common type of LRF after tri-modality therapy for locally-advanced EC. A limited subset of patients experience isolated SNF or PAF as first disease recurrence. The potential benefit of targeting additional SN or PA regions with RT is small and likely eclipsed by high rates of distant failure.

Pattern of local-regional relapse and survival after bimodality therapy for esophageal cancer: Implications for the surveillance strategy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4083-4083 ◽  
Author(s):  
Kazuki Sudo ◽  
Lianchun Xiao ◽  
Roopma Wadhwa ◽  
Takashi Taketa ◽  
Mariela A. Blum ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Distant Metastases ◽  
Rank Test ◽  
Evidence Based ◽  
Test Results ◽  
Surveillance Strategy ◽  
Gastroesophageal Junction Cancer ◽  
Kaplan Meier ◽  
Regional Disease

4083 Background: Evidence for definitive chemoradiotherapy (bimodality therapy [BMT]) has been established for patients with esophageal and gastroesophageal junction cancer (EGEJC) who do not qualify for surgery. Surveillance for these patients is often recommended but the literature lacks guidance for an evidence-based surveillance strategy after BMT. Methods: We analyzed 276 patients with EGEJC who underwent BMT and had pre- and postchemoradiation endoscopic biopsies and imaging studies available for review. Patients who underwent planned surgery or salvage surgery (SS) within 6 months from BMT were excluded. We reviewed the pattern of relapse over time. Local-regional disease (LRD) after BMT was classified as regional disease (RD) or luminal-only disease (LD). Overall survival (OS) probabilities were estimated using the Kaplan-Meier method and compared using the log-rank test. Results: For 276 patients, the median follow-up time was 53.0 months (95% confidence interval [CI], 47.3-58.7). A total of 184 (66.7%) patients had a persistent disease or relapse after BMT: 120 distant metastases (43.5% of 276) and 64 LRD (23.2% of 276). Of 64 LRD, 58 (91%) were diagnosed within 2 years of BMT and 63 (98%) were diagnosed within 3 years (see Table). Twenty-three of 64 LRD patients underwent SS. For patients with SS, the median OS time from diagnosis of LRD was 58.0 months (95% CI, not reached), and that for patients without SS was 9.0 months (95% CI, 7.3-10.7); this difference was highly significant (p < 0.001). Conclusions: Our data suggest that 91% of LRD occurred within 2 years after BMT and the OS with SS for LRD was better than that without SS. These data can contribute to the development of an evidence-based surveillance strategy. [Table: see text]

Arkansas Autotransplant (AT) Experience with > 2500 Myeloma (MM) Patients: Follow-Up Extending to >15 Years.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1149-1149
Author(s):  
Frits van Rhee ◽  
Guido Tricot ◽  
Elias Anaissie ◽  
Maureen Reiner ◽  
Maurizio Zangari ◽  
...  
Keyword(s):  
Cox Regression ◽  
Standard Of Care ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Kaplan Meier ◽  
Long Term Follow Up ◽  
Previously Treated Patients ◽  
The University

Abstract Background: AT’s have become the standard of care for MM. Long-term follow-up studies from large centers are critical to understand who benefits most and who should be considered for alternative treatment approaches. Patients and Methods: 2,605 MM patients receiving at least one AT at the University of Arkansas were considered for this study. Kaplan-Meier analysis was used to estimate median event-free (EFS) and overall survival (OS). Cox regression was used to evaluate independent prognostic factors of EFS and OS from AT. Results: Of the 2,605 patients, 891 were enrolled into front line Total Therapy (TT) protocols TT1/2/3 (TT); 1,012 were treated on protocols for previously treated patients (non-TT); and 702 were treated off protocol due to significant co-morbidities or patient/MD preference (non-P). Median EFS and OS for all patients are 29 mo and 51 mo; 10-yr EFS and OS are 18% and 23%; 12% survived &gt;15yr. Features independently predicting superior survival included TT (HR 0.51, p&lt;.001), absence of cytogenetic abnormalities (no CA) (HR 0.47, p&lt;.001), timely application of 2nd transplant (&lt; 6 months of 1st transplant) (HR 0.71, p&lt;.001) as well as B2M &lt; 3mg/L, CRP &lt; 6mg/dL, albumin &gt;=3g/dL, platelet count &gt;=100.000/microL (all p&lt;.001) and age &lt;65yr (p=.008). The figure depicts survival (landmarked at 6 months after 1st transplant) according to the number of favorable features present of the 5 strongest predictors (TT, 2 transplants within 6 months, no CA, low B2M, low CRP). Conclusion: This large single institution experience demonstrates that &gt; 10yr survival can be accomplished in over one-half of the patients presenting without CA (14%), with low levels of B2M and CRP and receiving TT and timely 2nd autotransplant. The worst constellation affected 5% of all patients presenting with at most 1 good-risk feature whose 5-yr survival was only 8%. Collectively, these data should serve as a standard for MM investigators and patients alike, against which long-term outcome of newer treatments should be measured. Figure Figure

Adjuvant chemoradiotherapy in patients (pts) with resectable gastric (GC) or gastroesophageal junction cancer (GEJC): A monoinstitutional experience.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14711-e14711
Author(s):  
Barbara Soini ◽  
Giuseppe Pani ◽  
Orazio Caffo ◽  
Michela Frisinghelli ◽  
Antonello Veccia ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Adjuvant Chemoradiotherapy ◽  
Consecutive Series ◽  
Gastroesophageal Junction Cancer ◽  
Chemotherapy Side Effects ◽  
Grade 3

e14711 Background: Several studies have investigated the role of adjuvant chemotherapy ± radiotherapy showing conflicting results. In this retrospective study we report our monoinstitutional experience in pts with resectable GC or GEJC, treated with adjuvant chemoradiotherapy. Methods: Between January 2004 and August 2010 a consecutive series of 48 pts (34 male and 14 female) with a median age of 61 years (range 45-76) underwent a curative resection for GC or GEJC. All pts were treated with adjuvant chemoradiotherapy according to Mc Donald protocol (NEJM 2001;345:725-30). Thirty-three tumors (69%) were localized at the antrum or corpus level and 9 (19%) at the cardias. Thirty-one patients (64 %) had a T3-T4 tumor and 46 (95%) had nodal metastases.Treatment consisted of fluorouracil (5FU) 425 mg/m2 per day plus leucovorin (L) 20 mg/m2 per day, for 5 days, followed by radiotherapy 4500 cGy at 180 cGy per day, given 5 days per week for 5 weeks, with 5FU (400 mg/m2 per day) and L (20 mg/m2 per day) during the first four and the last three days of radiotherapy. One month after the completion of RT, two five-day cycles of 5FU (425 mg/m2 per day) plus L (20 mg/m2 per day) were given one month apart. Results: The treatment was completed in all but 4 pts: 2 pts stopped treatment due to chemotherapy side effects, 1 pt died due to intestinal perforation, and 1 pt declined radiotherapy. Major toxicities consisted of: grade 3/4 neutropenia in 6 pts (12%) and grade 3/4 gastrointestinal toxicity in 8 pts (16 %). At a median follow-up of 25.5 months (range 7 - 68), the median disease free-survival (DFS) was 41 months (2-y DFS 59%, 3-y DFS 53%) and the median overall survival (OS) was 57 months (2-y OS 77%, 3-y OS 68%). Conclusions: Concomitant chemo-radiotherapy appears in our experience a feasible adjuvant regimen in curatively resected node positive gastric cancer. Despite the short follow-up, local control and survival rates seem promising and comparable to those reported in the literature.

Institutional retrospective review of presurgical cisplatin-based chemotherapy (chemo) in patients with urothelial carcinoma (UC): Gemcitabine+cisplatin (GC) versus dose-dense methotrexate, vinblastine, doxorubicin, cisplatin (ddMVAC).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 365-365
Author(s):  
Lauren Christine Harshman ◽  
Susanna J. Jacobus ◽  
Stephanie A. Mullane ◽  
Hope Feldman ◽  
Michelle S. Hirsch ◽  
...  
Keyword(s):  
Cox Regression ◽  
Tumor Resection ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Logrank Test ◽  
Exact Test ◽  
Kaplan Meier ◽  
Node Positive Disease ◽  
Muscle Invasive ◽  
Dose Dense

365 Background: Neoadjuvant cisplatin-based chemo is the standard of care for muscle invasive UC. ddMVAC and GC are frequently used regimens but have not been directly compared. The choice is often based on physician preference and toxicity profile. We interrogated a pre-existing database of UC patients (pts) for differences in efficacy and toxicity among them. Methods: From 2007-2013, consecutive pts who had received presurgical chemo prior to primary tumor resection for muscle invasive, non-metastatic UC were identified. Tolerability, toxicity and efficacy were evaluated. Rates were calculated by regimen and compared using Fisher’s exact test. Disease-free survival (DFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared by regimen using logrank test. Cox regression estimated hazard ratios (HR) in univariate and adjusted models. Results: Of the96 patients eligible for analysis (GC: 40, ddMVAC: 56), 42% of GC pts had ≥cT3 and 23% had cN+ compared to 62% and 39% with ddMVAC. pCR rate was 18% for GC and 27% for ddMVAC (p=0.33). With a median follow-up of 28 mo., 2-yr OS probabilities were 59% [95% CI:(39-74)] on GC and 77%[95%CI:(60-87%)] on ddMVAC (p=0.1). Conclusions: Despite having more clinical ≥T3 and node positive disease at baseline, ddMVAC is at least as active as GC and achieved a numerically higher rate of pCRs/≤pT1 than GC in our cohort. No unexpected toxicities surfaced. Dose delays, discontinuations, and most selected toxicities appeared higher with GC. Neither DFS or OS significantly differed between the two regimens, however, there was a trend to greater benefit with ddMVAC. [Table: see text]

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