Efficacy Of Neoadjuvant Treatment Research Articles

Neoadjuvant letrozole and palbociclib in patients with HR-positive/HER2-negative early breast cancer and Oncotype DX Recurrence Score ≥18: DxCARTES study

The effect of the addition of cyclin-dependent kinases 4 and 6 inhibitors to endocrine therapy in terms of molecular downstaging remains undetermined. Switching from a high-risk to a low risk Recurrence Score (RS) group could provide useful information to identify patients who might not require chemotherapy. The purpose of this study was to assess the biological and clinical activity of letrozole plus palbociclib as neoadjuvant treatment for patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with an initial Oncotype DX RS ≥18. Participants were women aged ≥18 years with HR-positive/HER2-negative, Ki67 ≥ 20%, stage II-IIIB early breast cancer with a baseline RS ≥18. Eligible patients with a pretreatment RS 18-25 (cohort A) and 26-100 (cohort B) received six 28-day cycles of letrozole (2.5 mg per day; plus goserelin if pre- or perimenopausal) plus palbociclib (125 mg per day; 3/1 schedule) before surgery. The primary endpoint for both cohorts was the proportion of patients who achieved an RS ≤25 at surgery or a pathological complete response (pCR). A total of 67 patients were enrolled, among which 65 were assessable for the primary endpoint (32 patients in cohort A and 33 in cohort B). At surgery, 22 (68.8%) patients in cohort A and 18 (54.5%) patients in cohort B had an RS ≤25 or a pCR [only 1 (3.0%) patient in cohort B], meeting the primary endpoint in cohort B (P < 0.01), but not in cohort A (P= 0.98). No new safety signals were identified. The efficacy of neoadjuvant treatment with letrozole plus palbociclib does not seem to depend on pretreatment RS for patients with RS ≥18. However, around half of patients with HR-positive/HER2-negative early breast cancer with an RS 26-100 at baseline achieved molecular downstaging with this regimen.

Combination of EGFR-TKI and Chemotherapy Versus EGFR-TKI Monotherapy as Neoadjuvant Treatment of Stage III-N2 EGFR-Mutant Non-Small Cell Lung Cancer.

The efficacy of neoadjuvant treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) monotherapy in patients with stage III-N2 EGFR-mutant remains unsatisfactory. This study explored the potential benefits of combining first-generation EGFR-TKI with chemotherapy as a neoadjuvant treatment for patients with stage III-N2 EGFR-mutant non-small cell lung cancer (NSCLC). The medical records of patients with III-N2 EGFR-mutant NSCLC who received neoadjuvant therapy with EGFR-TKI at Shanghai Chest Hospital from October 2011 to October 2022 were retrospectively reviewed. Patients with stage III-N2 EGFR-mutant NSCLC who received first-generation TKI combined with chemotherapy as neoadjuvant treatment were included in the combination group, and those who received EGFR-TKI monotherapy were included in the monotherapy group. The study assessed the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease-free survival (DFS), overall survival (OS), downstaging rates of pathologic lymph nodes (from stage N2 to N1 or N0), major pathologic response (MPR) rate, pathological complete response (PCR) rate, and safety. A total of 74 631 patients with EGFR-mutant NSCLC were screened, and 60 patients were included, 7 of whom did not undergo surgery after neoadjuvant targeted therapy. Of the remaining 53 patients, 15 received first-generation EGFR-TKI combined with chemotherapy as neoadjuvant treatment, and 38 received EGFR-TKI monotherapy. The median follow-up time was 44.12 months. The ORR was 50.0% (9/18) in the combination group and 40.5% (17/42) in the monotherapy group (P = .495). The MPR rate was 20.0% (3/15) and 10.5% (4/38) in the combination and monotherapy groups, respectively (P = .359). No patients achieved PCR in the combination group, while 3 (7.89%) attained PCR in the monotherapy group. The 2 groups did not differ in N2 downstaging rate (P = .459). The median DFS was not reached in the combination group, while it was 23.6 months (95% CI: 8.16-39.02) in the monotherapy group (P = .832). Adverse events observed were consistent with those commonly associated with the 2 treatments. Combination therapy with first-generation EGFR-TKI and chemotherapy could be considered a neoadjuvant treatment option for patients with stage III-N2 EGFR-mutant NSCLC, exhibiting acceptable toxicity. However, regarding short-term efficacy, combination therapy did not demonstrate superiority over EGFR-TKI monotherapy. Long-term follow-up is warranted for a more accurate assessment of the DFS and OS.

FRONTiER: A feasibility trial of nivolumab with neoadjuvant CF or DCF, FLOT therapy for locally advanced esophageal carcinoma (JCOG1804E)—Primary safety and short-term efficacy results for cohort E.

326 Background: The standard neoadjuvant treatment in Japan for resectable locally advanced esophageal squamous cell carcinoma (ESCC) is DTX + CDDP + 5-FU (DCF). In addition, immune checkpoint inhibitors (ICIs) have shown a survival benefit for ESCC and are promising as neoadjuvant treatment for several cancers. We previously reported that neoadjuvant CDDP + 5-FU + nivolumab (Nivo) or DCF + Nivo therapy was tolerable and showed promising efficacy for ESCC. However, the efficacy of neoadjuvant treatment and safety of subsequent surgery remain unclear for 5-FU + l-LV + L-OHP + DTX (FLOT), the global standard of care for perioperative esophagogastric adenocarcinoma, plus ICI for ESCC. Methods: JCOG1804E (FRONTiER) is a multi-cohort phase I study designed to evaluate the safety and efficacy of Nivo combined with neoadjuvant chemotherapy in ESCC. The eligibility criteria were histologically proven ESCC staged as cT1N1-3M0 or cT2-3N0-3M0 (8th UICC TNM classification), age 20-75 years, performance status (PS) ≤1, and no prior cancer therapy. The primary endpoint was the incidence of dose-limiting toxicity (DLT) from the initial dose to postoperative day 30. The secondary endpoints included adverse events during the perioperative period and at 30 days and the objective response rate, R0 resection rate, histopathological complete response rate, and completion rate of the protocol treatment including planned chemotherapy as below followed by R0 resection. Among five study cohorts, patients in cohort E were planned to receive four courses of FLOT+Nivo–5-FU (2600 mg/m2), l-LV (200 mg/m2), L-OHP (85 mg/m2), DTX (50 mg/m2), and Nivo (240 mg)–on day 1 every 2 weeks. Results: Of the 12 patients enrolled in cohort E (median age [range]: 64.5 [53-71] years, PS 0/1: 12/0, clinical stage I/II/III/IVA: 4/5/3/0), 4 developed DLT (grade 3 mucositis, erythema multiforme, and pneumonitis, n=1 each; grade 5 pneumonitis, n=1), which was within the prespecified range of safety (n ≤ 4). Other grades≥3 adverse events were neutropenia (n=7), leukopenia (n=6), fever, fatigue, febrile neutropenia, rash, elevated amylase, elevated hepatic enzyme, hypotension, and thrombocytopenia (n=1 each) during FLOT + Nivo, and anastomotic leakage (n=1) during the postoperative period. One patient discontinued FLOT + Nivo due to DLT of erythema multiforme, eleven patients (91.7%) completed the protocol treatment and R0 resection rate achieved 91.7% (11/12). In cohort E, the objective response rate in patients with measurable lesion was 0% (0/4). However, 5 patients (41.7%) achieved a pathological complete response, and 6 (50.0%) achieved a pathological complete response in primary tumors among 12 patients. Conclusions: Neoadjuvant FLOT + Nivo followed by surgery for locally advanced ESCC was tolerated and showed promising efficacy. Clinical trial information: NCT03914443 .

Neoadjuvant T-VEC + nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease: NIVEC trial.

9546 Background: Neoadjuvant systemic treatment with checkpoint inhibitors (ICI) has shown high response rates in patients with resectable metastasized melanoma. In patients with unresectable stage IIIB-IVA melanoma, intralesional treatment with talimogene laherparepvec (T-VEC) has also shown high and durable response rates. In this trial we investigated the safety and efficacy of neoadjuvant treatment with a combination of nivolumab and T-VEC in regionally metastasized melanoma. Methods: In this single arm phase II open-label trial (NCT04330430), 24 patients with resectable stage IIIB-IVA melanoma were included. Inclusion criteria were a RECIST 1.1 measurable lesion of ≥10mm and no prior systemic therapy. Treatment consisted of four doses of intralesional T-VEC (dose in ml according to the size of the lesions) and three doses of nivolumab 240 mg flat dose every two weeks, followed by surgery. The primary endpoint was pathological response rate according to the International Neoadjuvant Melanoma Consortium (INMC) criteria, secondary endpoints were delay or failure to perform surgery, event free survival (EFS) from time of randomization and safety. Results: Baseline characteristics are presented in the table. The overall pathological response rate was 74%, with a major pathological response (MPR = pathologic complete response (pCR) + near-pCR (max 10% viable tumor cells) in 15 patients (65%), a partial response in two patients (9%), a non-response in 4 patients (17%) and progression of disease (PD) in two patients (9%). In one patient the response was not evaluable because surgery was delayed due to a vena cava thrombosis. The two patients with PD had evidence of distant metastasis on preoperative imaging and therefore did not proceed to surgery as planned. Grade 2 treatment related adverse events (trAE) occurred in 7 patients (29%) and grade 3 in 2 (8%). There were no grade 4-5 trAEs. The 1-year EFS was 75% (95%CI 0.55-1). Conclusions: Neoadjuvant combination therapy of nivolumab and T-VEC for patients with regionally metastasized melanoma (satellite/in-transit +/- lymph node metastases) has an acceptable toxicity profile and has shown a significant major pathological response rate of 65%. Clinical trial information: NCT04330430 . [Table: see text]

Role of neoadjuvant treatment in resectable pancreatic cancer according to vessel invasion and increase of CA19-9 levels.

The efficacy of neoadjuvant treatment (NAT) for resectable pancreatic cancer remains debatable, particularly in patients with portal vein (PV)/superior mesenteric vein (SMV) contact and elevated serum carbohydrate antigen (CA) 19-9. This study investigated the clinical significance of PV/SMV contact and CA19-9 levels, and the role of NAT in resectable pancreatic cancer. A total of 775 patients who underwent surgery for resectable pancreatic cancer between 2007 and 2018 were included. Propensity score-matched (PSM) analysis (1:3) was performed based on tumor size, lymph node enlargement, and PV/SMV contact. Subgroup analyses were performed according to PV/SMV contact and CA19-9 level. Among the patients, 52 underwent NAT and 723 underwent upfront surgery. After PSM, NAT group showed better survival than upfront surgery group (median 30.0 vs 22.0 months, P= .047). In patients with PV/SMV contact, NAT tended to have better survival (30.0 vs 22.0 months, P= .069). CA19-9 >150 U/mL was a poor prognostic factor, with NAT showing a significant survival difference compared with upfront surgery (34.0 vs 18.0 months, P= .004). Neoadjuvant treatment showed better survival than upfront surgery in resectable pancreatic cancer. In patients with PV/SMV contact or CA19-9 >150 U/mL, NAT showed a survival difference compared to upfront surgery; therefore, NAT could be considered in these patients.

Efficacy of neoadjuvant treatment with or without pertuzumab in patients with stage II and III HER2-positive breast cancer: a nationwide cohort analysis of pathologic response and 5-year survival

BackgroundPathologic complete response (pCR) rates in early stage HER2-positive breast cancer improved after pertuzumab was added to neoadjuvant treatment. However, survival benefit is less-well established and seems mostly limited to node-positive patients. We used national cancer registry data to compare outcomes of patients treated with and without pertuzumab. MethodsWe identified stage II-III HER2-positive breast cancer patients treated with neoadjuvant trastuzumab-based chemotherapy between November 2013 until January 2016 from the Netherlands Cancer Registry. During that period pertuzumab was only available in the 37 hospitals that participated in the TRAIN-2 study. Missing grade and pCR-status were obtained from the Dutch Pathology Registry (PALGA) and cause of death from Statistics Netherlands. We used multiple imputation to impute missing data, multivariable logistic regression to evaluate the association between pertuzumab and pCR (ypT0/is, ypN0) and multivariable Cox regression models for overall survival and breast cancer specific survival (BCSS). ResultsWe identified 1124 patients of whom 453 received pertuzumab. Baseline characteristics were comparable, although tumor grade was missing more often in patients treated without pertuzumab (12% vs. 2%). Pertuzumab improved pCR rates (41% vs 65%, adjusted odds ratio [aOR] 2.91; 95% CI:2.20–3.94). After a median follow-up of 6.0 years, 5-year BCSS rates were 95% and 98% respectively (adjusted hazard ratio [aHR]: 0.58; 95% CI:0.36–0.95). Younger patients derived more benefit from pertuzumab, but no other significant interactions were found. ConclusionThese results support earlier data of a small survival benefit with the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy which is most meaningful in younger patients.

Neoadjuvant Treatment versus Upfront Surgery in Resectable Pancreatic Cancer: Clinical Significance of Portal Vein and Superior Mesenteric Vein Contact and Associated Prognostic Factors

Introduction: The efficacy of neoadjuvant treatment (NAT) in resectable pancreatic ductal adenocarcinoma (PDAC) remained debatable, particularly in portal vein (PV)/superior mesenteric vein (SMV) contact. This study investigated the clinical significance of PV/SMV contact and NAT in resectable PDAC patients.

Neoadjuvant programmed death-1 blockade plus chemotherapy in locally advanced esophageal squamous cell carcinoma.

BackgroundImmunotherapy is effective in treating unresectable esophageal squamous cell carcinoma (ESCC), but little is known about its role in the preoperative setting. The aim of this study was to evaluate the safety, feasibility and efficacy of neoadjuvant treatment with camrelizumab plus chemotherapy in locally advanced ESCC.MethodsPatients diagnosed with locally advanced ESCC were retrospectively included if they had received neoadjuvant camrelizumab plus nab-paclitaxel and S1 capsule followed by radical esophagectomy between November, 2019 and June, 2020 at Sun Yat-sen University Cancer Center. Primary endpoints were safety and feasibility. In addition, pathological response and the relationship between tumor immune microenvironment (TIME)/tumor mutational burden (TMB) and treatment response were also investigated.ResultsTwelve patients were included and they all received three courses of preoperative treatment with camrelizumab plus nab-paclitaxel/S1. No grade 3 or higher toxicities occurred. No surgical delay or perioperative death was reported. Nine patients (75%) responded to the treatment, four with a complete pathological response (pCR) and five with a major pathological response (MPR). Neither programmed death-ligand 1 (PD-L1) expression nor TMB was correlated with treatment response. TIME analysis revealed that a higher abundance of CD56dim natural killer cells was associated with better pathological response in the primary tumor, while lower density of M2-tumor-associated macrophages was associated with better pathological response in the lymph nodes (LNs).ConclusionsNeoadjuvant camrelizumab plus nab-paclitaxel and S1 is safe, feasible and effective in locally advanced ESCC and is worth further investigation.

Abstract 1601: Neoadjuvant programmed death-1 blockade plus chemotherapy in locally advanced esophageal squamous cell carcinoma

Abstract Background: Immunotherapy is effective in treating unresectable esophageal squamous cell carcinoma (ESCC), but little is known about its activities in the preoperative setting. We aimed to evaluate the safety, feasibility and efficacy of neoadjuvant treatment with camrelizumab plus chemotherapy in locally advanced ESCC. Methods: Patients diagnosed with locally advanced ESCC were retrospectively included if they had received three courses of neoadjuvant camrelizumab plus nab-paclitaxel and S1 capsule followed by radical esophagectomy between November, 2019 and June, 2020 at Sun Yat-sen University Cancer Center. Primary endpoints were safety and feasibility. Pathological response and association between tumor immune microenvironment (TIME)/tumor mutational burden (TMB) and treatment response were also explored. Results: Twelve patients were included. Neoadjuvant treatment with camrelizumab plus nab-paclitaxel/S1 was well tolerated without any grade 3 or higher toxicities. No surgical delay or perioperative death was reported. Nine patients (75%) responded to the treatment, four with a complete pathological response and five with a major pathological response. Treatment response by radiography was discordant with surgical pathology for five cases while endoscopic ultrasonography was accurate for the entire cohort. Neither programmed death-ligand 1 expression nor TMB was correlated with treatment response. In the TIME, higher abundance of CD56dim natural killer cells was associated with better pathological response in the primary tumor while lower density of M2-tumor-associated macrophages was associated with better pathological response in the lymph nodes. Conclusions: Neoadjuvant camrelizumab plus nab-paclitaxel and S1 is safe, feasible and effective in locally advanced ESCC and is worth further investigation. Citation Format: Guozhen Yang, Xiaodong Su, Hong Yang, Guangyu Luo, Chan Gao, Yating Zheng, Wenzhuan Xie, Mengli Huang, Yuezong Bai, Zhiqiang Wang, Peiqiang Cai, Haoqiang He, Jin Xiang, Muyuan Cai, Yijun Zhang, Chunhua Qu, Jianhua Fu, Qianwen Liu, Yi Hu, Jiudi Zhong, Yuanheng Huang, Qiyu Guo, Xu Zhang. Neoadjuvant programmed death-1 blockade plus chemotherapy in locally advanced esophageal squamous cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 1601.

Neoadjuvant PD-1 blockade combined with chemotherapy followed by concurrent immunoradiotherapy for locally advanced anal canal squamous carcinoma patients: Antitumor efficacy, safety and biomarker.

e15500 Background: Efficacy and safety of PD-1 inhibitors have been approved for the treatment of metastatic anal squamous cancer patients, but the efficacy of neoadjuvant treatment with PD-1 in anal squamous cancer patients has not yet been defined. We report results for the cohort of patients with locally advanced anal canal squamous carcinoma treated with neoadjuvant PD-1 inhibitor toripalimab and chemotherapy followed by concurrent immunoradiotherapy. Methods: Five locally advanced anal canal squamous carcinoma patients received 4 cycles of neoadjuvant PD-1 inhibitor toripalimab and Docetaxol and Cisplatin chemotherapy followed by concurrent immunoradiotherapy. Whole exome sequencing (WES) and mIHC were performed with the pretreatment tumor tissue for biomarker analysis. Results: Complete clinical response (cCR) was achieved in 4 patients after neoadjuvant treatment before radiotherapy while the other patient achieved near cCR. cCR was achieved in all the 5 patients 3 months after definitive immunoradiotherapy. Grade 3 toxicity was noted in 1 patient. Molecular testing revealed that PD-L1 expression (≥1%) in tumor and CD4/CD163 expression in tumor and paracancerous tissue were positively correlated with tumor shrinkage in the neoadjuvant treatment phase while TMB didn’t appear to significantly impact the response. Conclusions: PD-1 inhibitor combined with chemoradiotherapy has quite promising effect in locally advanced anal canal squamous carcinoma patients, with very mild toxicity. Pretreatment PD-L1 expression is positively correlated with tumor response to PD-1 inhibitor toripalimab and chemotherapy. It is worthy of further investigation in prospective clinical trial.

Thinking through the multimodal treatment of localized oesophageal cancer: the point of view of the surgeon.

This review examines current developments and controversies in the multimodal management of oesophageal cancer, with an emphasis on surgical dilemmas and outcomes from the surgeon's perspective. Despite the advancement of oncological neoadjuvant treatments, there is still no consensus on what regimen is superior. The majority of patients may still fail to respond to neoadjuvant therapy and suffer potential harm without any survival advantage as a result. In patients who do not respond, adjuvant therapy is still often recommended after surgery despite any evidence for its benefit. We examine the implications of different regimens and treatment approaches for both squamous cell cancer and adenocarcinoma of the oesophagus. The efficacy of neoadjuvant treatment is highly variable and likely relates to variability of tumour biology. Ongoing work to identify responders, or optimize treatment on an individual patient, should increase the efficacy of multimodal therapy and improve patient outcomes.

The efficacy of neoadjuvant treatment in locally advanced rectal cancer with dMMR.

615 Background: The incidence of Mismatch repair gene deficiency (dMMR) was about 15% in colorectal cancer, but mostly in right side colon cancer, while in locally advanced rectal cancer, it is very rare. As is known, adjuvant chemotherapy with 5FU alone was not recommended in stage II colon cancer with dMMR or MSI. However, in locally advanced rectal cancer with dMMR or MSI, the efficacy of neoadjuvant treatment with 5FU was not yet known. Methods: We enrolled patients with locally advanced rectal cancer from three prospective clinical trials, including the FOWARC study (N = 309), the mFOLFOXIRI neoadjuvant chemotherapy trial (N = 106) and the total neoadjuvant treatment with FOLFOX and radiotherapy (N = 129). From the 544 patients, 35 (6.4%) patients were dMMR, 133 patients with unknown status of MMR. Among the 35 patients, 10 patients received 5FU concurrent with radiotherapy (group A), nine patients underwent FOLFOX concurrent with radiation (group B), and 12 patients received FOLFOX neoadjuvant chemotherapy alone (group C). Another four patients underwent mFOLFOXIRI neoadjuvant chemotherapy alone (group D), including one patient with nivolumab as neoadjuvant treatment after chemotherapy. Results: Totally, 4 (11.4%) patients achieved pathologic complete response, and 13 (37%) patients had tumor downstaging to ypT0-2N0M0 (stage 0-I). In group A, the pCR rate was 10% (1/10), the tumor downstaging rate was 20% (2/10); In group B, the pCR rate was 33.3% (3/9), the tumor downstaging rate was 55.6% (5/9); In group C, the tumor downstaging rate was 41.7% (5/12). In group D, only one patient achieved pCR, and it is the one who received nivolumab as neoadjuvant treatment. Conclusions: The efficacy of neoadjuvant in locally advanced rectal cancer seemed not affected by the MMR status. But further study was needed.

Effect of neoadjuvant chemoradiotherapy on prognosis in resectable and borderline resectable pancreatic cancer with venous involvement.

343 Background: The efficacy of neoadjuvant treatment for pancreatic cancer (PC) remains to be established. In this study, we have retrospectively evaluated the impact of neoadjuvant chemoradiothrapy (NACRT) on perioperative and long-term clinical outcome in PC. Methods: One hundred eighty one patients who preoperatively received full-dose gemcitabine (1000mg/m2) with concurrent radiation of 54 Gy between 2006 and 2017 were analyzed. One hundred forty nine patients who proposed upfront surgery were served as control. Results: Among the 181 patients treated with NACRT, 23 (13%) couldn’t undergo pancreatic resection after NACRT because of distant metastasis in 10, tumor progression in 7 and poor PS in 6. While among the 149 patients who proposed upfront surgery, 10 (7%) couldn’t undergo pancreatic resection at laparotomy, because of distant metastasis in 8 and tumor progression in 2. In overall survival analysis of all patients with resected and unresected tumor, patients treated with NACRT had a better prognosis than those without (median survival time: 37.0 vs. 27.1M, P = 0.049). According to tumor resectability status including R (resectable), BR-P (borderline resectable with venous involvement) and BR-A (borderline resectable with arterial involvement) PC, in the R and BR-P group, overall survival was significantly better in the patients with NACRT (45.7 vs. 33.8M, P = 0.049, 61.7 vs. 14.6M, P = 0.002). Also only for resected tumors, patients treated with NACRT had a better prognosis than those without in the R and BR-P group (53 vs. 36.5M, P = 0.033, 61.7 vs. 14.6M, P = 0.002), while NACRT had no significant impact on prognosis in the BR-A group. The rate of pancreatic fistula, delayed gastric emptying and abdominal abscess were lower in the NACRT group than the control group. Furthermore, the lymph node metastasis rate, R0 resection rate and pathological stage were favorable in the NACRT group (P &lt; 0.001, P = 0.005, P &lt; 0.001). The completion rate of adjuvant chemotherapy was also higher in the NACRT group (P = 0.001). Conclusions: NACRT had a variety of favorable impact in PC treatment. In particular, it significantly improved the prognosis in the R and BR-P, but not BR-A.

Clinical efficacy of neoadjuvant treatment on early stage bulky cervical carcinoma

Objective To evaluate clinical efficacy and survival outcomes of neoadjuvant treatment on early stage bulky cervical carcinoma. Methods A total of 155 cases with bulky stage Ⅰb2 or Ⅱa2 cervical carcinoma in Affiliated Tumor Hospital of Shantou University Medical College from Nov. 2010 to Feb. 2015 was reviewed and divided into two groups according to pre-operative treatment 108 cases in the neoadjuvant treatment group and 47 cases in the control group who underwent radical surgery directly. The clinical, pathologic, and follow-up data were analyzed retrospectively. Results The total response rate of neoadjuvant treatment was 75.0%. Histological grade in neoadjuvant treatment group was better than the other group and the rate of deep myometrial infiltration was tend to low in neoadjuvant treatment group. There was no difference in pathological type, parametrial involvement, lymph node metastasis, and lymph vascular space invasion between two groups. The rate of postoperative treatment was similar (92.6% vs 87.2%, P>0.05). The overall survival rate of neoadjuvant treatment group was 96.4% and the other group was 88.9% (P=0.069). Conclusions Neoadjuvant treatment was effective for early stage bulky cervical carcinoma. It might reduce tumor histological grade and maybe improve the overall survival of patients. Key words: Chemotherapy, adjuvant; Radiotherapy, adjuvant; Uterine cervical neoplasms/TH

Clinical impact of neoadjuvant treatment in resectable pancreatic cancer: a systematic review and meta-analysis protocol

IntroductionAlthough the only curative strategy for pancreatic cancer is surgical resection, up to 85% of patients relapse after surgery. The efficacy of neoadjuvant treatment in resectable pancreatic cancer (RPC) remains...

Importance of resectability status in neoadjuvant treatment for pancreatic cancer

Much attention has been paid to neoadjuvant treatment (NAT) as a new strategy especially for borderline resectable pancreatic cancer (BRPC). However, the optimal indication of NAT remains undetermined. We analyzed 248 patients with pancreatic cancer (PC). One hundred resectable tumors were classified as R group. Sixty-nine tumors with venous involvement were classified as BR-P group, while 31 tumors with arterial involvement were classified as BR-A group. Ninety-nine patients received NAT. Furthermore, 48 unresectable locally advanced PC served as controls (LAPC group). Among them, 11 patients received adjuvant surgery afterwards (Ad-surg group). The overall median survival time in the R, BR-P and BR-A groups was 45.3, 24.8 and 16.8 months. In the R and BR-P groups, patients treated with NAT had a better prognosis than those without. In contrast, NAT had no impact on prognosis in the BR-A group. Patients treated with NAT in the BR-P, but not BR-A group, had a better prognosis than patients in the LAPC group. Furthermore, patients in the Ad-surg group had a significantly better prognosis than patients in the BR-A group. Borderline resectable pancreatic cancer with venous involvement, but without arterial involvement, may be a good indication for NAT. Our data highlight the importance of preoperative resectability assessment to evaluate the indication and efficacy of NAT.

SY11-3 - To Establish Neoadjuvant Chemotherapy for Pancreatic Cancer as a Standard Treatment

Background: Pancreatic cancer (PC) has a dismal prognosis even though it is consider to resectable. All resectable PC could not receive standard care due to unresectable factors found at the time of surgery or delayed recovery after surgery. Neoadjuvant chemotherapy (NAC) is an attractive alternative widely used in other types of cancer including esophageal or breast cancer.Aim: To establish NAC for pancreatic cancer as a standard treatment, we conducted retrospective and prospective clinical studies.Methods: 1) To estimate the feasibility and efficacy of NAC for PC, prospective phase II trials were conducted. NAC-GS2 (UMIN: 1504), NAC-GS3 (UMIN: 3402), and NAC-GS2 + 2 (UMIN: 9070) were conducted by multi-institutional setting. 2) To evaluate the feasibility and efficacy of neoadjuvant treatment, a large questionnaire survey was performed. 3) To verify the efficacy and safety of NAC-GS for resectable PC and prove the superiority on survival of NAC-GS against the standard surgery-first approach, phase II/III trial is now ongoing (UMIN: 9634).Results: 1) Between 2008 and 2010 in NAC-GS2 trial, 35 eligible patients received 2 cycles of GS with 90 % of relative dose intensity. Responses to NAC-GS included radiological tumor shrinkage (69%) and decreases in CA19-9 (89%). R0 resection was performed in 87%. The 2-year survival rate of total cohort was 45.7% (Motoi F et al. Ann Surg Oncol 2011). 2) A total of 971 patient's data were analyzed. The R0 resection rate was significantly higher in patients with resectable tumors with neoadjuvant treatment. No significant difference was observed in morbidity and mortality (Motoi F et al. JHPBS 2013). 3) Prep02/JSAP-05 trial has been started on 2013 with a sample size of 360 cases in randomized phase II/III setting from 70 institutions.Conclusions: The data from exploratory prospective trial and retrospective survey is encouraging of neoadjuvant therapy for PC. Phase III trial will clarify the survival benefit of NAC for PC.

Assessment of the Efficacy of Neoadjuvant Chemoradiotherapy in Rectal Cancer. Experience of an Irish Specialist Colorectal Unit

Aims: Neoadjuvant Chemoradiotherapy reduces the local recurrence rates in stage II and III rectal cancers. We evaluated the preoperative staging modalities and efficacy of neoadjuvant treatment in rectal cancer patients in our unit.