Impact Of Pathologic Complete Response Research Articles

Impact of Pathological Complete Response in Breast Cancer Following Neoadjuvant Therapy on Patient’s Outcome

Background: Patients who achieve a pathological complete response (pCR) after neoadjuvant therapy have better outcomes than patients with residual disease. Despite the excellent prognosis associated with achieving a pCR, recurrence still occurs. The study was conducted with the intent to evaluate factors associated with tumor recurrence and survival among patients achieving pCR after neoadjuvant therapy. Methods: We evaluated the medical records of patients with breast cancer who received neoadjuvant therapy and achieved pCR in our academic institute. The survival curve was estimated with the Kaplan-Meier method in patients who developed recurrence. Results: In our retrospective study 2,360 received neoadjuvant therapy out of which 315 (13.3%) who achieved pCR were included in this study. The mean age was 45.85 (range 21-92 years) and the mean duration of follow-up was 41.2 months. The clinical tumor stage T1-T2 represented 55%, T3-T4 was 44.1%, and node-positive was 54%. The primary endpoint was the correlation between pCR achieved after neoadjuvant therapy and disease-free survival or overall survival. . Predictors of pCR were clinical T-stage and receiving appropriate chemotherapy. We observed that patients who had an increased risk of recurrence after achieving pCR were those with clinical stage III-IV, patients with mastectomy, and those with triple-negative tumor subtype. Conclusion: Achieving pCR after neoadjuvant therapy is distinctly related to the improvement of survival, however patients who achieved a pCR, women younger than 50 years of age and those with stage III/IV disease have a higher risk of developing distant metastasis.

Impact of Pathologic Complete Response on the Prognosis of Triple-Negative Breast Cancer Patients: A Cohort Study.

Introduction Triple-negative breast cancer (TNBC) is a molecular subtype in which estrogen (ER)/progesterone receptor (PR) and human epidermal growth receptor 2 (HER2) expression does not occur.The objective of this study was to analyze the impact of pathologic complete response (pCR) after neoadjuvant chemotherapy on the prognosis of triple-negative breast cancer (TNBC) patients. Methods This cohort study was conducted in a private-sector oncology clinic located in the city of Teresina, Brazil. Medical charts of 532 breast cancer patients treatedfrom 2007 to 2020 were analyzed. Of these patients, 83 women with TNBC were selected (10 patients were excluded from the study). Univariate and multivariate analyses (Cox regression) were performed to evaluate the impact on patient survival, comparing patients with or without pCR. A significance level of 5% was set. Overall survival (OS) and disease-free survival (DFS) curves were constructed according to the Kaplan-Meier model. Results Angiolymphatic invasion and positive sentinel lymph node were associated with a lower OS and/or DFS in TNBC (p<0.05). The 10-year OS was 78% and 49%, and the 10-year DFS was 97% and 32% in patients with or without pCR, respectively. Conclusion pCR after neoadjuvant chemotherapy was associated with improvement in OS and DFS in TNBC patients.

The impact of pathological complete response on survival in patients with breast cancer and occurrence in different intrinsic subtypes: A retrospective observational study

ABSTRACT JOURNAL/crsat/04.03/02201859-202306020-00004/figure1/v/2023-08-03T140821Z/r/image-tiff Background: Pathological complete response (pCR), defined as non-invasive or in situ disease in the breast and regional lymph nodes following neoadjuvant chemotherapy (NACT) predicts oncologic outcomes. Objectives: The primary objective was to study the impact of pCR on survival in patients with breast cancer. The secondary objective was to assess the pCR rates in various intrinsic subtypes of breast cancer. Materials and Methods: This was a retrospective observational study conducted between 2015 and 2020 in the Department of Radiotherapy at R.G. Kar Medical College and Hospital, a tertiary care institution in Kolkata in eastern India, in women with locally advanced breast cancer (LABC) who received NACT. Patients were categorized based on age, menopausal status, and tumor characteristics, including stage, grade, and immunohistochemistry (IHC). The pCR rate was assessed, along with the median disease-free survival (DFS) and overall survival (OS). Results: A total of 251 patients (median age, 50 years; interquartile range, 43–57) were enrolled; 42 (16.7%) attained a pCR. Among the patients who attained a pCR, 7 (16.7%) had Luminal A, 8 (19.0%) had Luminal B, 14 (33.3%) had triple-negative breast cancer (TNBC), and 13 (31%) had HER2-positive disease. The median DFS for the entire cohort was 65 months (95% CI, 59.7–70.3); the median OS was not reached. The 5-year DFS in patients who attained a pCR was 67% compared to 52% in those who did not; P = 0.04. The 5-year OS was 92% and 74% in patients who attained a pCR and those who did not, respectively; P = 0.024. Conclusion: Patients with LABC who attain a pCR following NACT have better survival, both DFS and OS, compared to those who do not. The implications of this are particularly relevant in patients with HER2 enriched and triple negative breast cancer and are crucial in guiding the intensification of therapy in the adjuvant setting.

Impact of pathological complete response following neoadjuvant chemotherapy (gemcitabine, nab-paclitaxel, S-1) and radiation for borderline resectable pancreatic cancer: a case report and review of literature

BackgroundPancreatic cancer (PC) is a highly lethal malignancy, even if surgical resection is possible (median survival: < 30 months). The prognosis of borderline resectable pancreatic cancer (BR-PC) is even worse. There is no clear consensus on the optimal treatment strategy, including pre/postoperative therapy, for BR-PC. We report a patient with BR-PC who achieved clinical partial response with neoadjuvant chemoradiation therapy (NACRT) and underwent curative resection, resulting in pathological complete response (pCR).Case presentationA 71-year-old man with jaundice and liver dysfunction was referred to our department because of a 48-mm hypo-vascular mass in the pancreatic head with obstruction of the pancreatic and bile ducts and infiltration of superior mesenteric vein and portal vein. The lesion was identified as atypical cells which suggested adenocarcinoma by biopsy, and he was administered NACRT: gemcitabine and nab-paclitaxel, following S-1 and intensity modulated radiation therapy. After reduction in the tumor size (clinical partial response), pancreaticoduodenectomy was performed, and pCR achieved. Postoperative adjuvant chemotherapy with S-1 was initially administered and the patient is currently alive with no recurrence as of 2 years after surgery.ConclusionsNACRT is a potentially useful treatment for BR-PC that may lead to pCR and help improve prognosis.

Impact of Pathologic Complete Response following Neoadjuvant Chemotherapy ± Trastuzumab in Locally Advanced Breast Cancer.

Purpose This study was designed to examine the relationship between breast cancer molecular subtypes and pathological response to neoadjuvant chemotherapy (NAC) ± trastuzumab, in locally advanced breast cancer (LABC). Methods Female patients with LABC (T2–T4, N0–N2, and M0) who received neoadjuvant chemotherapy + trastuzumab if HER2+ subtype, followed by surgery and radiotherapy ± hormonal therapy, were identified. The primary endpoint was pathologic complete response (pCR) in the breast and axilla (ypT0/ypN0), with final analysis on disease-free survival (DFS) and overall survival (OS). Results Six hundred eighty-one patients with a median age of 44 years, premenopausal: 70%, median tumour size: 7.0 cm (range 4–11 cm), stage II B: 27% and III A/III B: 73%, ER+/HER2−: 40.8%, ER−/HER2−: 23%, ER+/HER2+: 17.7%, and ER−/HER2+: 18.5%. Overall pCR (ypT0/ypN0) was 23%. The pCR rates based on molecular subtypes were ER+/HER2−: 9%; ER+/HER2+: 29%; ER−/HER2−: 31%; and ER−/HER2+: 37%. At median follow-up of 61 months, ER+/HER2+ and ER+/HER2− subtypes had the best 5-year DFS and OS; meanwhile, ER−/HER2+ and ER−/HER2− subtypes had the worst. Conclusion Women with ER+/HER2− disease are the least likely to achieve pCR, with the highest rates in HER2+ and triple-negative subgroups. Degree of response is associated with OS; despite the comparatively higher likelihood of achieving pCR in ER−/HER2+ and triple-negative, these subgroups experience a survival detriment. We are consistent with the published data that patients who attain the pathological complete response defined as ypT0/ypN0 have improved outcomes.

PATHOLOGICAL COMPLETE RESPONSE TO NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

The impact of pathological complete response (pCR) on long-term treatment outcomes was analyzed in patients with locally advanced gastric cancer, who received prolonged neoadjuvant chemoradiotherapy.Material and Methods. The study included 45 patients with locally advanced gastric cancer. Neoadjuvant hyperfractionated accelerated radiotherapy at a total dose of 45 Gy was given concurrently with capecitabine and oxaliplatin chemotherapy. There were more men than women. The median age of the patients was 62 years. Tumors were most commonly located in the upper (46 %) and middle (38 %) thirds of the stomach. Low-grade adenocarcinoma and signet-ring cell carcinoma were the most common (65 %). According to a comprehensive examination, including CT and laparoscopy, tumors which invaded the subserous layer of the stomach wall were diagnosed in 17 (37.8 %) patients, and tumors which penetrated the serous layer or surrounding structures were found in 28 (62.2 %) patients. Regional lymph node metastases were detected in 38 (84.4 %) cases.Results. The absolute majority of patients underwent gastrectomy (43 patients, 96 %). Grade IaIb pathological response occurred in almost half of the patients (45.4 % of cases). Peritoneal metastases were found to be the most common mode of cancer dissemination; they were mostly observed in patients with poorly differentiated gastric cancer. Multivariate analysis revealed no effect of any of the factors characterizing the patient, tumor and completeness of treatment on the pathological response grade. However, a correlation between the clinical and morphological assessments of tumor regression was observed. In cases with complete or partial responses of the primary tumor and regional lymph nodes to chemoradiotherapy, 1aIb grades of pathological response were more frequently observed. It was also demonstrated a direct correlation between the pathological response grade and pathomorphological stage of the tumor (yp), as well as ypT and ypN categories. Analysis of long-term treatment outcomes showed that the overall and relapse-free 5-year survival rates were significantly higher in patients with 1a and Ib grades of pathological response. The overall 3-year survival rates were 70 ± 10 % and 41 ± 11 %, respectively (p=0.003). Multivariate analysis using the Cox regression model confirmed a statistically significant independent effect of the pathological response grade on the overall survival (p=0.015).Conclusion. Grade IaIb pathological response was observed in almost half of the patients, who received neoadjuvant chemoradiotherapy for locally advanced gastric cancer. No clinical and morphological factors influencing the pathological response grade were found. A correlation between the clinical and morphological assessments of tumor regression was observed. Patients with Ia-Ib pathological response had significantly higher overall and disease-free survival rates.

Abstract P2-16-24: Impact of pathologic complete response (pCR) and and biological features of residual tumor (RT) on prognosis after neoadjuvant chemotherapy (NC) in various invasive breast cancer (IBC) subtypes

Abstract Background: The outcomes of IBC pts who received NC could be different by Subtypes Methods: From 2000 to 2018 we treated 400 II-III stage IBC patients (pts) with NC. We recorded baseline characteristics, type of NC, type of surgery, pCR (defined as the absence of invasive cells in the breast and the lymph nodes regardless of DCIS), biological features of RT. pCR and survival outcomes (in term of Disease Free Survival-DFS, Relapse Free Survival-RFS and Overall Survival-OS) also on the basis of both pre- and post- NC Ki67 levels were assessed Results: Median age was 50 yrs (r. 25-75). Population consisted of: Luminal A (LA): 3.7% Luminal B (LB): 28.25% Luminal HER2 (LHER2): 28% HER2+HR- 13.5% Triple Negative (TN):21.25% Unknown:5.3% The NC was based on tri-weekly or dose-dense (only 22 cases) anthracyclines (A) followed by weekly taxanes (T) in HER2- (249), associated with weekly carboplatin (C) in more recent cases (48) of TN and T + trastuzumab (H) ± A (40) or C (102) in HER2+ pts. All pts but 18 did received surgery: 8 for distant metastases occurrence and 10 because still on NC. Quadrantectomy was performed in 205(52%) pts. pCR was achieved in 125 (31%) pts of which 30 with non invasive residual; further 10 patients showed RT ≤1 mm Relationship between pCR and SubtypesLA (%)LB (%)LHER2 (%)HER2+HR-TN (%)pCR6.715.938.450.041.2No pCR93.384.161.650.058.8p Value&amp;lt;0.001 pCR was reached in 41.5% in case of proliferation index by Ki67 ≥ 20% and in particular if &amp;gt; ki67 was &amp;gt; 40% regardless of Subtypes (p=0.001). All 166 HER2 + patients except 24 received H obtaining pCR in 70 (45.8%) of cases regardless chemotherapy type. pCR were 30.7% and 50% according to A- vs C-based regimen respectively. Twenty-six of 48 TN pts receiving C addition underwent S with pCR. The median Fup was 44.12 months (r: 1.35-232.6). The pCR was positively associated with DFS (HR 0.17, 95% CI 0.07-0.40), RFS (HR 0.26, 95% CI 0.13-0.50) and OS (HR 0.17, 95% CI 0.06-0.49) in overall population The association between pCR and long-term outcomes (DFS and RFS, but not OS) was greater in TN pts (EFS: HR 0.11, 95% CI 0.01-0.90; RFS: 0.12, 95% CI 0.06-0.71), in LHER2 (EFS: HR 0.20, 95% CI 0.04-0.87; RFS: 0.24, 95% CI 0.07-0.84) and in HER2+ (EFS: HR 0.11, 95% CI 0.01-0.90; RFS: 0.24, 95% CI 0.06-0.73) than in LA and LB. Postoperative low level of Ki67 (&amp;lt; 10%) reduced the risk of both relapse (HR = 0.37 ci 0.17-0.76) and death (HR = 0.29 ci 0.12-0.70) compared with pts with higher Ki67 levels. Conclusions: The pCR rate was significantly higher in aggressive Subtypes (HER2+ and TN) than luminals. Pts achieving pCR showed better RFS and OS compared to no pCR pts. Interestingly high pre-NC PI seems to predict the possibility obtaing pCR, while post-NC PI seems to be of prognostic value in pts who do not receive pCR, in particular in LB subtypes. Citation Format: Antonella Ferro, Alessia Caldara, Elisabetta Grego, Carlo Messina, Gabriella Berlanda, Paolo Cristofolini, Fabio Gasperetti, Salvatore Mussari, Carmine Fantò, Marvi Valentini, Marco Pellegrini, Mattia Barbareschi, Nicola Mirabassi, Giuseppe Carbone, Roberta Biondi, Renza Triolo, Silvia Lazzeri, Vincenzo Sabatino, Paola Bondioli, Orazio Caffo. Impact of pathologic complete response (pCR) and and biological features of residual tumor (RT) on prognosis after neoadjuvant chemotherapy (NC) in various invasive breast cancer (IBC) subtypes [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-16-24.

Impact of pathologic complete response on survival after neoadjuvant chemotherapy in early-stage breast cancer: a population-based analysis.

Achieving a pathologic complete response (pCR) has been associated with improved long-term outcomes in clinical trials. However, the benefit of achieving pCR across subtypes and its prognostic effect on real-world outcomes has not been well described. A retrospective analysis of the Breast Cancer Outcomes Unit database was undertaken to identify patients with stage I-III breast cancer treated with neoadjuvant chemotherapy from 2005 to 2010 in British Columbia. Patients were separated into two groups: those with pCR and those with residual invasive disease in the breast/axillary lymph nodes (RD). The primary endpoint was relapse-free survival (RFS). Key secondary endpoints included breast cancer-specific survival (BCSS) and overall survival (OS). Of 267 patients identified, 74 patients (28%) achieved pCR and 193 patients (72%) had RD. Median follow-up was 7.5years. The 5-year RFS was higher in the pCR group compared to the RD group (84% vs 70%; HR 0.45, p = 0.011). The 5-year BCSS was also higher in the pCR group than in the RD group (90% vs 77%; HR 0.39, p = 0.014). In multivariable analyses, pCR was associated with improved RFS (HR 0.39, p = 0.0077) and BCSS (HR 0.35, p = 0.015), whereas traditional pathological prognostic factors were not. Patients with TNBC who achieved pCR had improved RFS and BCSS compared to those with RD (HR 0.26, p = 0.020 and HR 0.35, p = 0.090, respectively). A similar but non-statistically significant trend was seen in the HER-2-positive and ER + subtypes. Achieving pCR after neoadjuvant chemotherapy was associated with clinically meaningful improvements in survival parameters in a real-world setting. The cumulative data support pCR as a valid surrogate endpoint in both clinical trials and population-based settings.

Impact of pathological complete response following neoadjuvant chemoradiotherapy in esophageal cancer.

Neoadjuvant radiochemotherapy (nRCT) followed by surgery has become the gold standard treatment in patients with locally advanced esophageal cancer. The pathological response is an important predictor in such patients. This work represents a single-center analysis investigating the impact of pathological complete response (pCR) on treatment outcome. All patients treated with nRCT followed by surgery between January 2005 and December 2015 were reviewed. The patients were categorized into two groups according to the pathological response following nRCT: pCR group and non-pCR group. Fifty-six patients with invasive cancer, 23 patients (41.1%) achieved pCR and 33 patients had non-pCR (58.9%) following nRCT. The average age was 62 years (±9.1), and most patients were males (83.9%). Histological types included squamous cell carcinoma (75%) and adenocarcinoma (25%). The total radiation dose was 45 Gy in 76.8% of the patients and 50.4 Gy in 23.2%. The median overall survival (OS) of the entire group was 3.5±1.2 years, and the 5-year OS rate was 38.2%, while the median disease-free survival (DFS) was 2.1±0.4 years and the 5-year DFS rate was 33.1%. The patients who achieved pCR had significantly higher 5-year OS and 5-year DFS rates: 47.2% and 48% compared to 27.3% and 21% for the non-pCR patients respectively (P=0.04, 0.03). The median time of local recurrence was 3.8±0.4 years in pCR group and 1.8±0.2 years in non-pCR group (P=0.01), while the median time of distant metastases in pCR group was 1.2±0.5 years and 1.1±0.2 years in non-pCR group (P=0.6). Complete pathological response predicts significantly higher rates of OS and DFS in patients with locally advanced esophageal cancer treated with nRCT followed by surgery.

The impact of pathological complete response after neoadjuvant chemoradiotherapy in locally advanced squamous cell carcinoma of esophagus

BackgroundThe impact of pathological complete response after neoadjuvant chemoradiotherapy on survival of patients with squamous cell carcinoma of esophagus is still controversial. We retrospectively investigated the survival outcome in this group of patients. MethodsNinety-eight patients with locally advanced squamous cell carcinoma of esophagus, who received neoadjuvant chemoradiotherapy were included in this retrospective analysis. Treatment protocols were radiotherapy with standard dose 50.4 Gy/28 fr, and chemotherapy with cisplatin 20 mg/m2 and 5-FU 800 mg/m2 for 4 days given on week 1 and 5. After neoadjuvant chemoradiotherapy is completed, patients who were eligible for surgery received surgery within 4–6 weeks. Patients who were not suitable for surgery were shifted to definite chemoradiotherapy. The primary end points were overall survival and progression-free survival. ResultsSixty-eight patients out of the ninety-eight patients received surgery after neoadjuvant chemoradiotherapy. There were 32 patients who achieved pathological complete response with a pCR rate of 47%. Thirty patients were shifted to definite concurrent chemoradiotherapy. The 2-year overall survival rate was 81.3% in the patients whose tumors showed a pCR and 58.3% in the patients with tumors that had a pathological partial response (p = 0.025). The 2-year overall survival in patients who received neoadjuvant chemoradiotherapy followed by surgery and definite chemoradiotherapy were 69.1% and 40.0%, respectively. There are 13 patients experienced grade 3–4 adverse event. ConclusionPathological complete response after neoadjuvant chemoradiotherapy is associated with a significant survival benefit in patients with locally advanced squamous cell carcinoma of esophagus. The toxicities related to neoadjuvant chemoradiotherapy were tolerable.

Impact de la réponse histologique complète à la chimiothérapie néo-adjuvante pour cancer du sein selon le sous-type moléculaire

ObjectivesThe aim of this study was to evaluate the impact of pathological complete response (pCR) on overall survival (OS) and recurrence-free survival (RFS) according to molecular subtypes in women treated for an invasive breast cancer after neoadjuvant chemotherapy (NAC). MethodsAll women (n=225) managed with a neoadjuvant chemotherapy for an invasive breast cancer in our institution between January 2007 and December 2013 were included. The characteristics of patients with pCR (pCR-1), breast pCR and axillary pCR were compared to those without pCR (pCR-0) according to the molecular subtypes: luminal A (n=62), luminal B (n=77), Her-2 (n=31) and triple negative (n=55). ResultsNAC concerned 225 patients of whom 36 (16%) had pCR. Achievement of pCR led to significantly better overall survival in women with Her-2 tumors (35% versus 100%, P=0.035) and also to significantly better locoregional survival in women treated for triple negative tumors (P=0.026). Predictive factors of pCR were a high pathologic grade: OR=2.39, IC 95% (1.19–4.83), P=0.008; Her-2 molecular subtype (P=0.008); positive estrogenic hormonal receptors (P=0.006), a positive Her-2 receptor: OR=2.58, IC 95% (1.20–5.54), P=0.01. ConclusionAchievement of pCR is an intermediate marker of survival in women managed with NAC for breast cancer.

The Impact of Pathologic Complete Response in Patients with Neoadjuvantly Treated Locally Advanced Rectal Cancer—a Large Single-Center Experience

Small cohort studies demonstrated better oncologic outcomes for patients with pathologic complete response (PathCR) after neoadjuvant treatment for locally advanced rectal cancer. This study reviews long-term outcomes of a large cohort of clinically stage II/III rectal cancer patients who received neoadjuvant chemoradiation and surgery. This is a retrospective analysis of a single-center cohort, including all clinical stage II/III rectal cancer patients who received neoadjuvant chemoradiation and surgery between 2004 and 2014 (n = 271). Cox regressions were done to assess the influence of PathCR on recurrence-free survival (RFS) and overall survival (OS), adjusting for postoperative chemotherapy, clinical AJCC staging, comorbidity, and age where appropriate. PathCR patients had significantly lower distant recurrence rates (4 vs. 15.8%; P = 0.028) and lower disease-specific mortality rates (0 vs. 8.1%; P = 0.052), compared to patients with residual disease. PathCR was associated with longer RFS (HR, 5.6 [95% CI 1.3–23.1] P = 0.018) and longer OS (HR, 3.4 [1.31–10.0] P = 0.014) compared to having pathological residual disease. This large single-center study shows that patients with PathCR have significant longer RFS and OS than patients with residual disease on pathology after neoadjuvant chemoradiation.

Pathologic complete response after neoadjuvant chemotherapy in HER2-overexpressing breast cancer according to hormonal receptor status

ObjectiveFor patients with HER2-positive breast cancer, the prognostic impact of pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) is unclear when stratified by hormonal receptor (HR) status; however, the impact of pCR on survival when stratified by hormonal receptor (HR) status is uncertain. Patients and methodsThis multicenter retrospective study investigated the predictors of pCR and its prognostic value in Japanese patients 366 HER2-positive breast cancer who received NAC. pCR was defined as no invasive residual tumor in the breast or axilla. ResultsMedian follow-up was 55 months. Multivariate analysis revealed that HR status (OR, 0.37; p < 0.001) was one of the independent predictors of pCR. Five-year recurrence-free survival was higher in HR-negative patients with pCR (93%) than in those without pCR (68%), and pCR was independently prognostic (hazard ratio, 0.32; p = 0.005). However, 5-year recurrence-free survival was not different between HR-positive patients with pCR (94%) and those without pCR (84%), and pCR was not significantly prognostic (hazard ratio, 0.53; p = 0.39). In addition, 5-year overall survivals were high and similar (97% in pCR, 94% in non-pCR). Among 204 patients treated with neoadjuvant trastuzumab, pCR was not significantly prognostic in the HR-positive group (hazard ratio, 0.63; p = 0.56). ConclusionOur study suggested that the HER2-positive HR-positive patients had a good prognosis despite the lower achievement rate of pCR, whose prognostic impact was smaller than that in the HER2-positive HR-negative patients. The treatment strategy for HER2-positive breast cancer can be stratified by HR status.

Impact of pathologic complete response on disease-free survival in patients with esophagogastric adenocarcinoma receiving preoperative docetaxel-based chemotherapy

BackgroundThe aim of this study was to evaluate the impact of pathologic complete response (pCR) on outcome in patients with gastric or esophagogastric junction (EGJ) adenocarcinoma after neoadjuvant docetaxel/platin/fluoropyrimidine-based chemotherapy. Patients and methodsPatients received at least one cycle of chemotherapy for potentially operable disease. Pretreatment clinicopathologic factors and pCR were investigated. Disease-free survival (DFS), overall survival (OS) and tumor-related death were correlated with pCR. ResultsOne hundred twenty patients were included in this analysis. Eighteen patients (15%) achieved a pCR. Tumor localization in the EGJ was identified as the only significant predictor of pCR (P = 0.019). Median follow-up was 41.1 months. Median DFS and OS for all patients were 24.1 and 48.6 months, respectively. Median DFS for patients with a pCR was not reached versus 22.1 months non-pCR patients (hazard ratio, HR 0.38; 3-year DFS: 71.8% and 37.7%, respectively, P = 0.018). While OS was not significantly different, the risk for tumor-related death was significantly lower for pCR patients compared with non-pCR patients (3-year cumulative incidences of 6.4% and 45.4%, respectively, P = 0.009). ConclusionA pCR following preoperative docetaxel/platin/fluoropyrimidine indicates favorable outcome in patients with gastric or EGJ adenocarcinoma. Tumor location in the EGJ is associated with a higher pCR rate.

Impact of pathologic complete response to preoperative docetaxel-based chemotherapy on disease-free survival in esophagogastric adenocarcinoma.

123 Background: The aim of this study was to evaluate the impact of pathologic complete response (pCR) on outcome in patients with gastric or esophagogastric junction (EGJ) adenocarcinoma after treatment with preoperative docetaxel/platin /fluoropyrimidine based chemotherapy. Methods: This analysis of a prospective database identified patients who received at least one cycle of preoperative docetaxel/platin/fluoropyrimidine-based chemotherapy for at least T3/4 and N+ disease. An association of pretreatment clinicopathologic factors and pCR was investigated. Overall survival, disease-free survival and disease-specific survival were analyzed according to the achievement of a pCR. Results: A total of 120 patients received preoperative docetaxel-based chemotherapy and underwent subsequent resection of the primary tumor. 15 pts (13%) had distant metastases (M1) at initial diagnosis. 18 patients achieved a pCR in the primary (15%). Median follow-up was 41.1months. The median DFS and OS for the whole population was 24.1 and 48.6 months, respectively. DFS was significantly prolonged in pCR compared to non-pCR patients (HR 2.65, 95% CI 1.1- to 6.2; 3-year DFS probability: 71.8%±10.7 and 37.7%±5.1, respectively, P-value log-rank test=0.018). For patients with a pCR the median DFS was not reached and for those without pCR the median DFS was 22.1 months. Patients with a pCR showed an almost 50% decreased risk of death compared to non-pCR patients (HR 0.53; 95%CI 0.23 to 1.23; P=0.131). Disease-specific survival (DSS) was significantly longer in pCR vs. non-pCR patients (HR 0.188, 95%CI 0.046-to 0.77; P= 0.021). Two clinicopathological parameters were identified as predictors of pCR: tumor localization in the EGJ (p=0.019) and intestinal tumor type according to Laurén’s classification (p=0.042). Conclusions: The analysis confirms that pCR to neoadjuvant chemotherapy is a predictor of favourable patient outcome in patients with gastric or EGJ adenocarcinoma. Tumor location in the EGJ and intestinal histology represent factors significantly associated with the achievement of pCR.

Docetaxel-Based Preoperative Chemoradiation in Localized Gastric Cancer: Impact of Pathological Complete Response on Patient Outcome

This study was conducted to evaluate the feasibility, efficacy, and toxicities of docetaxel-based induction chemotherapy and chemoradiotherapy in patients with localized gastric or gastroesophageal adenocarcinoma. Patients with localized, operable gastric or gastroesophageal adenocarcinoma received two cycles of induction chemotherapy of fluorouracil, docetaxel, and cisplatin (TPF) followed by 45 Gy of radiation and concurrent fluorouracil plus docetaxel then surgery for nonmetastatic patients. Forty-one patients were included. Pretreatment T3 was encountered in 56 % of patients while 61 % had N1 disease. A pathologic complete response (CR) was noted in 24 % of patients. Pathologic response was significantly associated with baseline T stage (P < 0.001) and N stage (P = 0.002). The 3-year overall survival (OS) and disease-free survival were 47.3 and 42.1 %, respectively. OS was significantly correlated with R0 resection (P = 0.027), pathological response (P = 0.01), dissected pathologically positive lymph node (P = 0.037), and postsurgery (T) stage (P = 0.02). Toxicities were manageable and there were no treatment-related deaths. Docetaxel-based chemoradiotherapy in localized gastric adenocarcinoma patients resulted in 24 % path CR and was not associated with a higher percentage of postoperative complications. A well-designed randomized controlled trial is mandatory to further endorse this evolving approach.

Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes

The exact definition of pathologic complete response (pCR) and its prognostic impact on survival in intrinsic breast cancer subtypes is uncertain. Tumor response at surgery and its association with long-term outcome of 6,377 patients with primary breast cancer receiving neoadjuvant anthracycline-taxane-based chemotherapy in seven randomized trials were analyzed. Disease-free survival (DFS) was significantly superior in patients with no invasive and no in situ residuals in breast or nodes (n = 955) compared with patients with residual ductal carcinoma in situ only (n = 309), no invasive residuals in breast but involved nodes (n = 186), only focal-invasive disease in the breast (n = 478), and gross invasive residual disease (n = 4,449; P < .001). Hazard ratios for DFS comparing patients with or without pCR were lowest when defined as no invasive and no in situ residuals (0.446) and increased monotonously when in situ residuals (0.523), no invasive breast residuals but involved nodes (0.623), and focal-invasive disease (0.727) were included in the definition. pCR was associated with improved DFS in luminal B/human epidermal growth factor receptor 2 (HER2) -negative (P = .005), HER2-positive/nonluminal (P < .001), and triple-negative (P < .001) tumors but not in luminal A (P = .39) or luminal B/HER2-positive (P = .45) breast cancer. pCR in HER2-positive (nonluminal) and triple-negative tumors was associated with excellent prognosis. pCR defined as no invasive and no in situ residuals in breast and nodes can best discriminate between patients with favorable and unfavorable outcomes. Patients with noninvasive or focal-invasive residues or involved lymph nodes should not be considered as having achieved pCR. pCR is a suitable surrogate end point for patients with luminal B/HER2-negative, HER2-positive (nonluminal), and triple-negative disease but not for those with luminal B/HER2-positive or luminal A tumors.

O-268 Induction chemoradiotherapy and surgical resection for non-small cell lung carcinomas of the superior sulcus: Prediction and impact of pathologic complete response (CR)

O-268 Induction chemoradiotherapy and surgical resection for non-small cell lung carcinomas of the superior sulcus: Prediction and impact of pathologic complete response (CR)