Usefulness Of Adjuvant Chemotherapy Research Articles

An expatiate review on adjuvant chemotherapy of colorectal cancer

Colorectal cancer is the second leading cause of cancer-related death and the third most common cancer globally. For loco regional colon cancer, surgery is the sole curative option. Adjuvant chemotherapy aims to eliminate micro metastases and increase survival. It has been most convincingly proven in stage III illness, even though there is ongoing debate on the usefulness of adjuvant chemotherapy for stage II illness. For the past fifteen years, six months of adjuvant chemotherapy with an oxaliplatin-based chemotherapy has been the accepted standard of care for stage III colon cancer. It is still advised to use 6 months of adjuvant chemotherapy for individuals with stage II illness and high clinicopathological risk. Chemo radiation therapy (CRT) is frequently used as neoadjuvant or adjuvant therapy in the treatment of stage II and stage III rectal cancers because this cancer type has a higher risk of local recurrence than other cancer types.

Survival benefit of adjuvant chemotherapy after resection of Stage I lung adenocarcinoma containing micropapillary components.

The usefulness of postoperative adjuvant chemotherapy (ACT) for patients with stage I lung adenocarcinoma with micropapillary (MIP) components remains unclear. We analyzed whether postoperative ACT could reduce recurrence in patients with stage I lung adenocarcinoma with MIP components, thereby improving their overall survival (OS) and disease-free survival (DFS). Data for patients with pathologically confirmed stage I lung adenocarcinoma with MIP components from January 2012 to December 2018 were retrospectively analyzed. OS and DFS were analyzed in groups and subgroups. Overall, 259 patients were enrolled. Patients who received ACT in stage IA showed significantly better survival than did those with no-adjuvant chemotherapy (NACT); (5-year OS 89.4% vs. 73.6%, p < 0.001; 5-year DFS 87.2% vs. 66.0%, p = 0.008). A difference was also observed for in-stage IB patients (5-year OS 82.0% vs. 51.8%, p = 0.001; 5-year DFS 76.0% vs. 41.11 %, p = 0.004). In subgroup analysis based on the proportion of MIP components, patients with 1%-5% MIP components had a significantly better prognosis in the ACT group than in the NACT group (5-year OS 82.4% vs. 66.0%, p = 0.005; 5-year DFS 76.5% vs. 49.1%, p = 0.032). A similar difference was observed for patients with MIP ≥5% (5-year OS 80.7% vs. 47.8%, p = 0.009; 5-year DFS 73.11% vs. 43.5%, p = 0.007). Among patients with stage I lung adenocarcinoma with MIP components, those who received ACT showed significant survival benefits compared to those without ACT. Patients with lung adenocarcinoma with MIP components could benefit from ACT when the MIP was ≥1%.

Identification of patients at high risk for recurrence in carcinoma of the ampulla of Vater: Analysis in 460 patients.

Carcinoma of the ampulla of Vater (CAV) shows a favorable prognosis compared to that with the other periampullary tumors, while some cases have a poor prognosis. The aims of the present study are to clarify the clinicopathological factors associated with poor recurrence-free survival (RFS) in patients with CAV after curative resection and to validate the usefulness of adjuvant chemotherapy (AC). The study design is a multicenter retrospective cohort study. Patients with CAV who underwent pancreaticoduodenectomy between January 2008 and December 2020 at 26 hospitals were analyzed. The 30 clinicopathological factors were evaluated. A propensity score matching (PSM) was used to compare between patients with and without AC. Finally, 460 patients were analyzed. Median duration of follow-up was 47.2 months. Twenty-one prognostic factors associated with poor RFS were identified by univariate analysis. In multivariate analysis, aged ≥71, tumor diameter ≥12 mm, pT2 or higher stage (pT≥2), portal vein invasion (PV+), venous invasion(V+), and node positive disease (pN+) were independent prognostic factors for poor RFS. Out of 80 patients who received AC, 63 patients were assigned to analysis for PSM. The results showed no beneficial effect of AC on RFS. The preoperative factors potentially predicting pT≥2, V+, and/or N+ were at least one of following; (1) CA19-9 > 37 IU/mL, (2) ulcerative or mixed type appearance, (3) except for well-differentiated tumor, or (4) except for intestinal subtype of histology. Aged ≥71, tumor diameter ≥12 mm, pT≥2, PV+, V+, and pN+ were independent prognostic factors for poor RFS in patients with CAV. An additional therapeutic strategy may be desirable in CAV patients at high risk for recurrence.

Concordance between 21-gene recurrence score assay and clinicopathological predictive models in early-breast cancer patients cared for at a cancer center in Colombia.

The genomic-based 21-gene recurrence score assay (21-GRSA) allows to determine the usefulness of adjuvant chemotherapy in patients with luminal-type early breast cancer (LTEBC). Additional predictive models have also been developed, such as Magee equations (ME), the Predict model (PM), and the Tennessee nomogram score (TNS). To evaluate the concordance between 21-GRSA, ME, PM and TNS. Patients with unifocal LTEBC and 21-GRSA, ME, PM and TNS results were included. A subgroup analysis of women older than 50 years was carried out. Concordance between the models and 21-GRSA was evaluated using Cohen's kappa index (KI). One-hundred and twenty-two women were included. Concordance between 21-GRSA and ME (KI = 0.35) and PM (KI = 0.24) was fair (p < 0.001). Concordance between 21-GRSA and TNS was inferior (KI = 0.16, p = 0.04). Eighty patients older than 50 years with sufficient data to calculate all three predictive models were included. Concordance was found between the low-risk classification on 21-GRSA and all three combined models in 36/37 patients (negative predictive value of 97.3%). 21-GRSA can be omitted in women older than 50 years with LTEBC classified with low risk scores on all three predictive models.

Final analysis of a prospective controlled trial of the efficacy of uracil and tegafur/leucovorin for stage II colon cancer with risk factors for recurrence using propensity score-based methods (JFMC46-1201).

117 Background: The usefulness of adjuvant chemotherapy for stage II colon cancer with high-risk factors for recurrence has not been established. Methods: This was a prospective, non-randomized controlled study based on patients’ selection of treatment options, including randomized therapeutic decision-making. High-risk factors were defined as having at least one of the following factors: T4, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, and &lt; 12 dissected lymph nodes. UFT (300 mg/m2/day) plus LV (75 mg/day) were orally administered for 6 months after surgery. The primary endpoint was disease-free survival (DFS) after adjusting for risk factors using propensity sore matching (1:2) and inverse probability of treatment weighting (IPTW) in the non-randomized arm. The secondary endpoints were overall survival (OS) and safety. Results: 1902 (98%) and 36 (2%) patients were enrolled in the non-randomized and randomized arms, respectively between May 2012 and April 2016. There were too few patients in the randomized arm and these were therefore excluded from the analysis. Eligible patients were divided into two groups: A, patients who selected surgery alone (n = 641); B, patients who selected UFT/LV treatment (n = 1239). Of the eligible patients, 402 in group A and 804 in group B were propensity score-matched. The 5-year DFS rate (95% confidence interval) was significantly higher in group B (76.3% [73.1-79.1]) than in group A (68.8% [63.9-73.2]) {hazard ratio [HR] 0.66 [0.51–0.84, P = 0.0008]}. The 5-year OS rates were not significantly different between group B and group A [HR 0.74 (95% CI 0.50–1.10, P = 0.1391)]. Using IPTW, significantly higher 5-year DFS [HR 0.71 (95% CI 0.59–0.86, P = 0.0006)] and overall survival [HR 0.66 (95% CI 0.49–0.90, P = 0.0122)] rates were observed in group B compared with group A. Multivariate analysis revealed that male sex, over 70 years old, T4, &lt; 12 dissected lymph nodes, and no adjuvant chemotherapy were significant risk factors for recurrence. Conclusions: Adjuvant chemotherapy with UFT/LV significantly improves DFS. Oral UFT/LV as adjuvant chemotherapy shows efficacy with an acceptable safety profile for stage II colon cancer with risk factors. Clinical trial information: UMIN000007783 .

Analysis of the treatment outcome of ampulla of Vater carcinoma and the usefulness of postoperative adjuvant chemotherapy.

692 Background: Patients with ampulla of Vater carcinoma with lymph node metastasis reportedly have a poor prognosis and require postoperative adjuvant therapy. However, due to the small number of published cases, the efficacy of postoperative adjuvant therapy has not yet been established with a high level of evidence. Objective: The aim of this study was to describe the outcome of patients surgically treated for ampulla of Vater carcinoma in our department, evaluate the effectiveness of adjuvant chemotherapy (AC), and clarify which patient groups may benefit from AC. Methods: The study cohort comprised 46 patients who underwent surgery for ampulla of Vater carcinoma in our department from October 2005 to March 2022. We evaluated the clinicopathological background characteristics (tumor size, gross morphology, pancreatic/duodenal invasion, peripancreatic head lymph node metastasis), overall survival (OS), and relapse-free survival (RFS), and compared the OS and RFS in patients with versus without AC. We then analyzed the factors related to the long-term outcome of patients treated for ampulla of Vater carcinoma. Results: During a median observation period of 33.7 months, the 5-year OS and RFS were 63.1% and 61.7%, respectively. Recurrence was observed in 14 patients (30%), with recurrence occurring less than 1 year postoperatively in seven patients (15%). Fifteen patients received AC (chemotherapy regimen: S-1 in 11 patients, GEM in four). The 5-year OS rates with and without AC were 70.3% and 48.2%, respectively (p=0.093). The 5-year RFS rates with and without AC were 72.5% and 42.8%, respectively (p=0.058). Univariate analysis of the total patient cohort showed that the factors related to 5-year RFS were pancreatic invasion (p=0.01), duodenal invasion (p=0.03), and N+ (p=0.004). In multivariate analysis, the only factor related to 5-year RFS was N+ (HR 3.53; 95% CI, 0.99–12.6; p=0.03). The 5-year OS rates in patients with and without N+ were 77.1% and 42.7%, respectively (p=0.04). The 5-year RFS rates in patients with and without N+ were 80.4% and 32.1%, respectively (p=0.004). Conclusions: AC showed a tendency to be effective in preventing postoperative recurrence of ampulla of Vater carcinoma. AC may be particularly beneficial in N+ cases.

Non-small-cell lung cancer involving the pleura: a narrative review on the diagnostic and therapeutic pathway

: Visceral pleural invasion (VPI) is considered a challenging topic in the management of patients with non-small-cell lung cancer (NSCLC) since it has been incorporated into the last edition of tumor, node, metastasis (TNM) staging as a size independent T2 factor. VPI presents adverse outcomes and poorer prognosis, with higher rate of mediastinal lymph node metastases and malignant pleural effusion. In literature few studies investigated it, therefore there is still debate on the global management of these patients, from the preoperative staging to the optimal surgical procedure and the postoperative follow-up or the need of adjuvant chemotherapy. Our work is a narrative review taking into consideration the most recent and relevant articles concerning VPI and NSCLC. We have summarized the most appropriate diagnostic pathway, surgical approach and post-operative management in order to give these patients the best therapeutic option. The preoperatively prediction of pleural invasion is still too weak to ensure a preoperative upstaging. On the other hand, lobectomy with adequate lymph node dissection seems to be the most appropriate therapeutic option in these patients. Furthermore, there is no evidence of the usefulness of adjuvant chemotherapy and the lack of clinical trials leads clinicians to evaluate case-by-case the global management of these patients.

Management of elderly patients with bone and soft tissue sarcomas: JCOG Bone and Soft Tissue Tumor Study Group.

Approximately, 40% of bone sarcomas and 60% of soft tissue sarcoma arise in patients aged ≥65years. However, because sarcoma is very rare, there is little evidence regarding the management of elderly patients with sarcoma. Age has been reported as a prognostic factor in patients with sarcomas. The standard therapy for all localized bone and soft tissue sarcomas is surgical resection, even in elderly patients. Radiation or ion-beam therapy can be considered for unresectable sarcomas. Although adjuvant chemotherapy is standard for osteosarcoma, the usefulness of adjuvant chemotherapy for elderly patients has not been verified; therefore, it may not be recommended for elderly patients with osteosarcoma. For elderly patients with advanced osteosarcoma, if general conditions permit, doxorubicin- and/or ifosfamide-based regimens as well as molecular-targeted therapies, including sorafenib, regorafenib and everolimus, may be considered, although these drugs have not been approved for sarcoma in Japan. Adjuvant chemotherapy with doxorubicin plus ifosfamide is recommended for patients with high-risk localized soft tissue sarcoma if they are aged ≤70years. For first-line treatment of advanced soft tissue sarcoma in elderly patients, doxorubicin monotherapy is considered to be the standard regimen, and pazopanib can be an alternative. For second-line treatment, gemcitabine-based regimens, pazopanib, trabectedin and eribulin may be options for elderly patients with advanced soft tissue sarcoma.

Prognosis and adjuvant chemotherapy for patients with positive peritoneal cytology in stage IA endometrial cancer

This study evaluated the influence of positive peritoneal cytology (PPC) on the prognosis of patients with stage IA endometrial cancer, and the usefulness of adjuvant chemotherapy in their treatment. We retrospectively analyzed the data of patients with stage IA endometrial cancer admitted in our hospital between 2005 and 2015. Among 989 patients who underwent peritoneal cytology, 135 (13.7%) had PPC. Multivariate analysis extracted several independent risk factors for recurrence in stage IA patients, including those with PPC. Adjuvant chemotherapy did not cause a significant difference in the 5-year relapse-free survival rate in patients with PPC (p = 0.78). Similarly, the 5-year recurrence-free survival rate with or without chemotherapy was not different among type II cancer patients (p = 0.11). However, the baseline risk of 5-year relapse-free survival without chemotherapy in patients with PPC and type II was very low (66.7%). While PPC was an independent risk factor for recurrence in stage IA endometrial cancer, adjuvant chemotherapy did not influence the survival rate in patients with PPC. While it is controversial whether adjuvant chemotherapy should be administered in stage IA uterine cancer with only PPC as a prognostic factor, it should be considered for early-stage patients who have multiple risk factors for recurrence.

Survival Outcomes of Gemcitabine Plus S-1 Adjuvant Chemotherapy after Surgical Resection for Advanced Biliary Tract Cancer

Introduction: The usefulness of adjuvant chemotherapy in biliary tract cancer (BTC) is poorly reported. This study aimed to evaluate the effectiveness and safety of adjuvant gemcitabine plus S-1 (GS) chemotherapy after curative surgical resection for BTC. Methods: 225 BTC patients who underwent surgical resection between January 2006 and May 2019 were enrolled in this study. Twenty-seven patients received adjuvant chemotherapy with GS (GS group), whereas 67 patients underwent surgery alone (S group). Twenty-three matching pairs were derived through propensity score (PS) matching analysis. Patients received 12 cycles of adjuvant chemotherapy (70 mg/m² oral S-1 for 7 consecutive days plus intravenous gemcitabine 1,000 mg/m² on day 7). The primary end point was recurrence-free survival (RFS). The secondary end points were the 1-, 2-, and 3-year RFS and overall survival (OS) rates, tolerability, and frequency of grade 3/4 toxicity. Results: The completion rate was 81.5%; no treatment-related deaths were observed. Grade 3/4 adverse events were seen in 40.7% of the patients. RFS (3-year RFS rate: 59.3% vs. 39.1%, p = 0.049) and OS (3-year OS rate: 71.7% vs. 53.4%, p = 0.008) were significantly better in the GS group than in the S group among PS-matched pairs. Discussion/Conclusion: GS chemotherapy after curative surgery was well tolerated, showed better clinical benefit in the adjuvant setting, and can effectively reduce BTC recurrence.

Adjuvant and neoadjuvant chemotherapy for osteosarcoma: JCOG Bone and Soft Tissue Tumor Study Group.

The usefulness of adjuvant chemotherapy for high-grade osteosarcoma was established by two randomized, controlled trials conducted in the 1980s, which used six drugs, doxorubicin, cisplatin, high-dose methotrexate, bleomycin, cyclophosphamide and actinomycin D. Since then, development has been promoted in the direction of introducing preoperative chemotherapy, changing post-operative adjuvant chemotherapy according to histological effects, adding ifosfamide as a key drug and strengthening adjuvant chemotherapy. No clinical trials, however, have shown the effectiveness of study treatment, and the improvement of treatment results during that time has been slight, although the JCOG0905 study is now going to verify the effectiveness of introducing ifosfamide for patients who experienced limited preoperative therapeutic effects. We are desperately looking for a breakthrough.

Hemangiopericytoma: Incidence, Treatment, and Prognosis Analysis Based on SEER Database.

Background Hemangiopericytomas are rare tumors derived from pericytes surrounding the blood vessels. The clinicopathological characteristics and prognosis of hemangiopericytoma patients remain mostly unknown. In this retrospective cohort study, we assessed the clinicopathological characteristics of hemangiopericytoma patients, as well as the clinical usefulness of different treatment modalities. Material and Methods. We collected the clinicopathological data (between 1975 and 2016) of hemangiopericytoma and hemangioendothelioma patients from the Surveillance, Epidemiology, and End Results (SEER) database. Incidence, treatment, and patient prognosis were assessed. Results Data from 1474 patients were analyzed in our study cohort (hemangiopericytoma: n = 1243; hemangioendothelioma: n = 231). The incidence of hemangiopericytoma in 2016 was 0.060 per 100,000 individuals. The overall survival (OS) and cancer-specific survival (CSS) did not differ between patients with hemangioendothelioma and those with hemangiopericytoma (P = 0.721, P = 0.544). The tumor grade had no effect on the OS of hemangiopericytoma patients. Multivariate analysis revealed the clinical usefulness of surgery in hemangiopericytoma patients (HR = 0.15, 95% confidence interval: 0.05-0.41, P < 0.001). In contrast, radiotherapy did not improve OS (P = 0.497) or CSS (P = 0.584), and chemotherapy worsened patient survival (P < 0.001). Additionally, the combination of surgery and radiotherapy had a similar effect with surgery alone on hemangiopericytoma patient survival (OS: P = 0.900; CSS: P = 0.156). Surgery plus chemotherapy provided a worse clinical benefit than surgery alone (P < 0.001). Conclusions Our findings suggested that hemangiopericytoma had a similar prognosis with hemangioendothelioma. Surgery was the only effective treatment that provided survival benefits in hemangiopericytoma patients, while the clinical usefulness of adjuvant chemotherapy or radiotherapy was limited.

Perioperative treatments for stage IB-IIB uterine cervical cancer.

Japan Society of Gynecologic Oncology guidelines recommended either radical hysterectomy-based approach or the definitive radiotherapy including concurrent chemoradiotherapy as primary treatment for patients with not only stage IB1/IIA1, but also stages IB2, IIA2 and IIB. Based on pathological findings of surgical specimens, patients who underwent radical hysterectomy are divided into three recurrent-risk groups, low-risk, intermediate, and high-risk groups. Although some authors reported the usefulness of adjuvant chemotherapy for intermediate/high-risk patients, radiotherapy was standard adjuvant treatment for pathological-risk patients after radical hysterectomy. It has been uncertain whether neoadjuvant chemotherapy followed by radical hysterectomy is beneficial for stage IB2-IIB patients. Recently, the randomized phase III study revealed that neoadjuvant chemotherapy followed by radical hysterectomy failed to improve survival of stage IB2-IIB patients compared to concurrent chemoradiotherapy. Majority of stage IB2-IIB patients are required adjuvant radiotherapy after radical hysterectomy. The multimodality strategy consisting of radical hysterectomy followed by adjuvant radiotherapy is associated with not only impaired quality of life, but also conflicting of cost-effectiveness. Thereby, some authors investigated the significance of multimodality strategy consisting of chemotherapy before/after radical hysterectomy for stage IB2-IIB cervical cancer. Multimodality strategy consisting of radical hysterectomy/perioperative chemotherapy needs higher curability of radical hysterectomy, higher response to perioperative chemotherapy and less perioperative complications. Consequently, gynecologic oncologists have to examine the patients strictly before treatment and judge whether radical hysterectomy-based approach or definitive irradiation is appropriate for the patient with stage IB-IIB cervical cancer.

Pre-operative chemotherapy is the key to the next stage of gastric cancer treatment

Currently, surgery remains the only approach to cure gastric cancer. However, improvement of prognosis by surgical resection alone is limited, and peri-operative chemotherapy is necessary (1). In recent years, several large clinical trials have shown the effectiveness of adjuvant post-operative chemotherapy for gastric cancer (2-4). In contrast, the usefulness of adjuvant pre-operative chemotherapy has not been fully demonstrated.

A multivariate model to define risk groups among patients with curatively resected stage I and II colon carcinoma: Final report of a retrospective cohort study.

696 Background: Patients with stage I or II colon carcinoma (CC) have a 10 or 20% risk, respectively, of presenting recurrent disease after a potentially curative surgical resection and adjuvant chemotherapy have not improved survival in this setting. In this study, we present a multivariate model to define risk groups. Methods: Consecutive cases with stage I and II CC treated at a single cancer center in Mexico City, from January 1992 to December 2016, were included in this 25-year cohort. Clinical history and biochemical data were registered, and colon resection was performed with curative intention with standard lymphadenectomy. Standard hematoxylin-eosin slides and CDX2 immunohistochemistry (IHC) slides were analyzed by two independent pathologists. The Kaplan-Meier method and Cox model were used to analyze the association of prognostic factors and overall survival (OS). Results: 3,301 cases of colorectal cancer were treated during this study, but only 556 patients with stage I and II CC were included in the database: 266 women (47.8%) and 290 males (52.2%) (mean age 57.9 years); 52 (9.4%), 431 (77.5%), 36 (6.5%) and 37 (6.7%) were pTNM stages I, IIa, IIb, and IIc, respectively. R0 resection was performed in 548 patients (98.6) and R1 in 8 (1.4%). Location in the left colon (HR 1.63), hemoglobin (HR 0.93), serum albumin (HR 2.45), prognostic nutritional index 0.915), platelet count (HR 0.998), body mass index (HR 0.94), basal carcinoembryonic antigen (HR 1.0), TNM stage [stage I reference category, IIa (HR 5.46), IIb (HR 4.42), IIc (HR 9.28)], R1 residual disease (HR 2.8), negative CDX2 IHC (HR 2.1), and use of adjuvant chemotherapy (HR 0.629) were included in the final model as independent predictors of OS (model p &lt; 0.0001).Predicted survival functions using this model defined three distinct risk groups. Conclusions: This multivariate model adds significant prognostic value to the pTNM classification. This model can be useful for stratifying prognosis in patients with CC and will aid in the design of randomized clinical trials evaluating the usefulness of adjuvant chemotherapy in this subgroup of patients with CC.

Controversies in the multimodality management of locally advanced rectal cancer.

Neoadjuvant radiotherapy previous to radical surgery, both as short-course radiotherapy and as long-course radiotherapy combined with 5-FU-based chemotherapy (LCRCT), is routinely used in the management of locally advanced rectal cancer, with consistent benefits in the reduction in the local relapse risk. Unfortunately, survival benefits have been elusive to demonstrate with this approach, especially in the setting of radical surgery in the form of total mesorectal excision (TME). Concerns about over-treating early-stage patients and about the possible long-term side effects have also cast more doubts in a blanket approach of treating all patients with neoadjuvant radiotherapy, especially with LCRCT. In this review of selected controversial topics in locally advanced rectal cancer, we examine the benefits and drawbacks for the use of both neoadjuvant approaches in the TME era, the role of the intensification of the neoadjuvant regimens with new chemotherapy agents and modifications of the radiotherapy regimen, the usefulness of adjuvant chemotherapy, especially after LCRCT and surgery, and the management of elderly and/or frail patients. Finally, we offer some future perspectives in the management of these patients.

The clinical implication of Charlson age comorbidity index and usefulness of adjuvant chemotherapy in resected pancreatic cancer

The clinical implication of Charlson age comorbidity index and usefulness of adjuvant chemotherapy in resected pancreatic cancer

Adjuvant chemotherapy beneficial for select early-stage, low-grade serous ovarian cancer patients

Objectives: Low-grade serous ovarian cancer (LGSC) is a rare subtype of ovarian serous carcinoma accounting for only 6% of all serous ovarian carcinoma. These tumors are considered to be relatively chemoresistant because of their tumor biology, making the role of adjuvant chemotherapy in early stage LGSC unclear. Herein, we sought to identify any chemotherapy benefit in overall survival among women with early-stage LGSC.Methods: The National Cancer Data Base was queried for all patients diagnosed from 1998 to 2012 with stage IA–IC LGSC. Only patients with nodal dissection were included for analysis. Χ2 test, logistic regression analysis, and log-rank test were used to analyze chemotherapy utilization and survival.Results: Of the 2,260 patients identified as having stage I LGSC, 1,481 had nodal dissection and were included for analysis. Chemotherapy was used in 15%, 21%, and 60% for stage IA, IB, and 1C, respectively. Age, insurance type (uninsured, private, Medicare/Medicaid), and stage were all associated with increased likelihood of receiving chemotherapy. Only age, Charlson-Deyo Comorbidity index, and insurance type were statistically significantly associated with survival on univariate and multivariable analysis. The 5-year overall survival (OS) for stage IA, IB, and IC without chemotherapy are 92%, 84%, and 88%, respectively. The 5-year OS for stage IA, IB, and IC with chemotherapy are 96%, 95%, and 94% respectively. A statistically significant difference in survival was seen in patients with stage IC receiving chemotherapy (P =.009).Conclusions: This is the largest dataset to date to look at the usefulness of adjuvant chemotherapy in stage I LGSC. Age, comorbidities, and type of insurance were associated with survival in this cohort, but the substages of stage I LGSC were not. However, adjuvant chemotherapy does confer a survival benefit in patients with stage IC LGSC. Although typically considered relatively chemoresistant with an overall good prognosis, adjuvant chemotherapy demonstrates a survival benefit of 6.8% and should be considered in these patients. Objectives: Low-grade serous ovarian cancer (LGSC) is a rare subtype of ovarian serous carcinoma accounting for only 6% of all serous ovarian carcinoma. These tumors are considered to be relatively chemoresistant because of their tumor biology, making the role of adjuvant chemotherapy in early stage LGSC unclear. Herein, we sought to identify any chemotherapy benefit in overall survival among women with early-stage LGSC. Methods: The National Cancer Data Base was queried for all patients diagnosed from 1998 to 2012 with stage IA–IC LGSC. Only patients with nodal dissection were included for analysis. Χ2 test, logistic regression analysis, and log-rank test were used to analyze chemotherapy utilization and survival. Results: Of the 2,260 patients identified as having stage I LGSC, 1,481 had nodal dissection and were included for analysis. Chemotherapy was used in 15%, 21%, and 60% for stage IA, IB, and 1C, respectively. Age, insurance type (uninsured, private, Medicare/Medicaid), and stage were all associated with increased likelihood of receiving chemotherapy. Only age, Charlson-Deyo Comorbidity index, and insurance type were statistically significantly associated with survival on univariate and multivariable analysis. The 5-year overall survival (OS) for stage IA, IB, and IC without chemotherapy are 92%, 84%, and 88%, respectively. The 5-year OS for stage IA, IB, and IC with chemotherapy are 96%, 95%, and 94% respectively. A statistically significant difference in survival was seen in patients with stage IC receiving chemotherapy (P =.009). Conclusions: This is the largest dataset to date to look at the usefulness of adjuvant chemotherapy in stage I LGSC. Age, comorbidities, and type of insurance were associated with survival in this cohort, but the substages of stage I LGSC were not. However, adjuvant chemotherapy does confer a survival benefit in patients with stage IC LGSC. Although typically considered relatively chemoresistant with an overall good prognosis, adjuvant chemotherapy demonstrates a survival benefit of 6.8% and should be considered in these patients.

Treatment Rationale and Study Design for Clinical Trial on the Efficacy of UFT/LV for Stage II Colorectal Cancer With Risk Factors for Recurrence (JFMC46-1201)

BackgroundThe usefulness of adjuvant chemotherapy for stage II colon cancer has not been established. Meanwhile, the presence of stage II colon cancer with high-risk factors for recurrence has been reported. To our knowledge, no prospective study of adjuvant chemotherapy for stage II colon cancer with high-risk factors has been implemented to date. Patients and MethodsThis study is a prospective nonrandomized controlled study based on patients' selection of treatment option, including randomized therapeutic decision-making, to evaluate the usefulness of adjuvant chemotherapy with tegafur-uracil (UFT) with leucovorin (LV) for stage II colon cancer with high-risk factors for recurrence, compared with surgery alone. Five courses of UFT/LV therapy will be given as follows: UFT (300 mg/m2/d) with LV (75 mg/d) will be orally administered in 3 doses per day. Treatment will be received daily for 28 days, followed by a 7-day rest or will be received daily for 5 days, followed by a 2-day rest. For both regimens, 1 course will last 5 weeks, and 5 courses will be given. The primary end point is disease-free survival. A propensity score matching will be conducted based on 7 variables that represent risk factors to minimize selection bias in a comparison between the nonrandomized arms. For this nonrandomized comparison, a target sample size is set at 1200 (400 and 800 patients for the surgery alone and UFT/LV groups, respectively) and 1720 patients will be enrolled. In this study we aim to evaluate the therapeutic usefulness of adjuvant chemotherapy with UFT/LV for stage II colorectal cancer with risk factors for recurrence.

Extramural extension as indicator for postoperative adjuvant chemotherapy in Stage IIA (pT3N0) colon cancer

The usefulness of adjuvant chemotherapy (CMT) in patients with Stage IIA colon cancer remains unclear. The present study aimed to investigate extramural extension as an indicator for adjuvant CMT. Data were reviewed from 202 consecutive patients with Stage IIA colon cancer that underwent curative surgery between 1995 and 2007. The distance of the extramural extension (DEE) was measured histologically. The optimal prognostic cut-off point of the DEE for oncologic outcomes was statistically determined. The eligible surviving patients had been followed for a median period of 75 months (range: 2–210 months). Patients were subdivided into two groups according to the optimal cut-off point; DEE ≤5 mm (pT3a) and DEE >5 mm (pT3b). The pT3b was the most powerful independent risk factor for postoperative recurrence (P = 0.0324, HR: 3.04, 95% CI: 1.098–8.408), and was significantly correlated with distant metastasis (P = 0.0161 HR: 5.19, 95% CI: 1.765–15.239). The recurrence-free and cancer-specific 5-year survival rates in patients with pT3b were significantly lower than in patients with pT3a (81.5% vs. 95.4%, P = 0.0003 and 85.9% vs. 97.4%, P = 0.0007, respectively). pT3b could be an important risk factor for distant metastasis in Stage IIA colon cancer. Postoperative adjuvant CMT may be indicated for patients with pT3b.J. Surg. Oncol. 2013; 108:358–363. © 2013 The Authors. Journal of Surgical Oncology Published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.