Patterns of adjuvant therapy use and survival outcomes in patients with rectal cancer not receiving neoadjuvant therapy in an Australian cohort.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 675-675
Author(s):  
Kate Jessica Wilkinson ◽  
Sharlyn Kang ◽  
Stephanie Hui-Su Lim ◽  
Cheok Soon Lee ◽  
Ray Asghari ◽  
...  

675 Background: Consensus international guidelines recommend the use of neoadjuvant chemo-radiotherapy in patients with stage II-III rectal cancer. Despite this, due to factors including inaccurate/under-staging, patient co-morbidities and acute presentations, a proportion will undergo up-front surgical resection. The survival benefit of adjuvant therapy is unclear in this real world, non-trial population. Methods: A retrospective analysis of patients presenting with stage II-III rectal adenocarcinoma in South Western Sydney and Illawarra Shoalhaven Health Districts, Australia, between 2006 to 2015 was performed. Data was extracted from electronic health records, with institutional ethics approval. Treatment modalities, clinicopathological, recurrence and survival data were analyzed. The primary endpoint was overall survival (OS) by treatment modality. Results: 549 patients were identified, of which 295 (54%) underwent up-front surgical resection without neoadjuvant therapy. Of this cohort, 137 (46%) had no adjuvant therapy (Group A), 103 (35%) had adjuvant chemotherapy alone (Group B), and 55 (19%) had adjuvant radiotherapy +/- chemotherapy (Group C). Receipt of any adjuvant treatment was significantly associated with improved OS (5 year OS 56 vs. 79%, HR 0.44, 95% CI 0.3 – 0.6, p < 0.0001) and recurrence free survival (5 yr RFS 25% vs. 47%, HR 0.66, 95% CI 0.5 – 0.9, p=0.01), but not cancer specific survival (5yr CSS 75 vs. 80%, HR 0.78, 95% CI 0.5 – 1.3, p = 0.30). Group B had improved OS compared to Group A (5 yr OS 56% vs. 80%, HR 0.35, 95% CI 0.22 – 0.55, p < 0.0001). There was a trend to improved OS in Group C vs. Group A (5yr OS 56.0% vs. 69.2%, HR 0.79 95% CI 0.6 – 1.01, p = 0.052). The improved OS in Group B versus Group A remained significant in multivariate analysis (HR 0.41, 95% CI 0.22 – 0.77, p = 0.005). Conclusions: Adjuvant chemotherapy improved OS in this real world cohort, and there was a trend to a benefit with adjuvant chemo-radiotherapy. However, the lack of difference in cancer specific survival suggests that this benefit may be partly driven by patient selection bias. Further exploratory analyses to identify sub-groups deriving a cancer specific survival benefit are required.

2020 ◽  
Vol 10 ◽  
Author(s):  
Zhiju Chen ◽  
Shaowei Li ◽  
Yehong Wang ◽  
Zhiming Fu ◽  
Ning Liu ◽  
...  

BackgroundIt is well known that neoadjuvant radiotherapy could reduce local recurrence followed by surgical resection. However, evidence about oncologic efficacy of radiotherapy and survival benefit of adjuvant chemotherapy after neoadjuvant radiotherapy is still lacking.MethodsThis retrospective propensity score-matched cohort study identified patients with pathologically confirmed rectal cancer and receiving surgery with curative intent from the Surveillance, Epidemiology, and End Results database from 2004 through 2014. Overall survival was compared using the stratified log-rank test. Multivariate Cox regression analysis was used for identifying risk factor and developing prediction nomogram.ResultsA total of 22,008 (11,004 for each group) propensity-matched patients were identified. In the context of receiving adjuvant chemotherapy after surgical resection, there was no significant difference in terms of overall survival between surgery alone group and neoadjuvant radiotherapy and surgery group, whether for stage I (log-rank test p = 0.467), stage II (log-rank test p = 0.310), or stage III (p = 0.994). In case of receiving a prior combination therapy of neoadjuvant radiotherapy and surgery, the following adjuvant chemotherapy could significantly improve overall survival for patients with stage I (log-rank test p &lt;0.001), stage II (log-rank test p = 0.038), and stage III (log-rank test p = 0.014). Nomogram integrating clinicopathologic factors was developed to predict survival benefit associated with neoadjuvant radiotherapy. Calibration and ROC curves validated promising performance for the nomogram.ConclusionPatients with rectal cancer underwent neoadjuvant radiotherapy yield acceptable outcomes and are more likely to benefit from adjuvant chemotherapy in terms of overall survival. These data would be evidential for advocating consistency in guideline adherence to the use of adjuvant chemotherapy after neoadjuvant radiotherapy.


2019 ◽  
Vol 37 (34) ◽  
pp. 3212-3222 ◽  
Author(s):  
Emmanouil Fokas ◽  
Michael Allgäuer ◽  
Bülent Polat ◽  
Gunther Klautke ◽  
Gerhard G. Grabenbauer ◽  
...  

PURPOSE Total neoadjuvant therapy is a new paradigm for rectal cancer treatment. Optimal scheduling of preoperative chemoradiotherapy (CRT) and chemotherapy remains to be established. PATIENTS AND METHODS We conducted a multicenter, randomized, phase II trial using a pick-the-winner design on the basis of the hypothesis of an increased pathologic complete response (pCR) of 25% after total neoadjuvant therapy compared with standard 15% after preoperative CRT. Patients with stage II or III rectal cancer were assigned to group A for induction chemotherapy using three cycles of fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT (50.4 Gy) or to group B for consolidation chemotherapy after CRT. Secondary end points included toxicity, compliance, and surgical morbidity. RESULTS Of the 311 patients enrolled, 306 patients were evaluable (156 in group A and 150 in group B). CRT-related grade 3 or 4 toxicity was lower (37% v 27%) and compliance with CRT higher in group B (91%, 78%, and 76% v 97%, 87%, and 93% received full-dose radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin in groups A and B, respectively); 92% versus 85% completed all induction/consolidation chemotherapy cycles, respectively. The longer interval between completion of CRT and surgery in group B (median 90 v 45 days in group A) did not increase surgical morbidity. A pCR in the intention-to-treat population was achieved in 17% in group A and in 25% in group B. Thus, only group B ( P < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis. CONCLUSION Up-front CRT followed by chemotherapy resulted in better compliance with CRT but worse compliance with chemotherapy compared with group A. Long-term follow-up will assess whether improved pCR in group B translates to better oncologic outcome.


Author(s):  
Shozo Ohsumi ◽  
Sachiko Kiyoto ◽  
Mina Takahashi ◽  
Seiki Takashima ◽  
Kenjiro Aogi ◽  
...  

Abstract Purpose Scalp cooling during chemotherapy infusion to mitigate alopecia for breast cancer patients is becoming widespread; however, studies regarding hair recovery after chemotherapy with scalp cooling are limited. We conducted a prospective study of hair recovery after chemotherapy with scalp cooling. Patients and methods One hundred and seventeen Japanese female breast cancer patients who completed planned (neo)adjuvant chemotherapy using the Paxman Scalp Cooling System for alopecia prevention were evaluated for alopecia prevention in our prospective study. We evaluated their hair recovery 1, 4, 7, 10, and 13 months after chemotherapy. Primary outcomes were grades of alopecia judged by two investigators (objective grades) and patients’ answers to the questionnaire regarding the use of a wig or hat (subjective grades). Results Of 117 patients, 75 completed scalp cooling during the planned chemotherapy cycles (Group A), but 42 discontinued it mostly after the first cycle (Group B). Objective and subjective grades were significantly better in Group A than in Group B throughout 1 year, and at 4 and 7 months after chemotherapy. When we restricted patients to those with objective Grade 3 (hair loss of > 50%) at 1 month, Group A exhibited slightly faster hair recovery based on the objective grades than Group B. There was less persistent alopecia in Group A than in Group B. Conclusions Scalp cooling during chemotherapy infusion for Japanese breast cancer patients increased the rate of hair recovery and had preventive effects against persistent alopecia.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lei Chen ◽  
Chenghai Zhang ◽  
Zhendan Yao ◽  
Ming Cui ◽  
Jiadi Xing ◽  
...  

Abstract Background This study compared the long-term efficacy of different durations of adjuvant chemotherapy for patients with gastric cancer after radical gastrectomy with D2 lymphadenectomy. Methods We retrospectively identified 428 patients with stage II–III gastric cancer who underwent D2 gastrectomy between 2009 and 2016. Patients were divided into four groups according to the duration of adjuvant chemotherapy, including 0 week (no adjuvant, group A), 20 to 24 weeks (completed 7–8 cycles every 3 weeks or 10–12 cycles every 2 weeks, group B), and 12 to18 weeks (completed 4–6 cycles every 3 weeks or 6–9 cycles every 2 weeks, group C), and less than 12 weeks (received up to 3 cycles every 3 weeks or 5 cycles every 2 weeks, group D). The chemotherapy regimens included XELOX, SOX, and FOLFOX. 5-year overall survival (OS) and disease-free survival (DFS) were analyzed. Results The 5-year OS rates for groups A, B, C, and D were 52.3, 73.7, 72.0, and 53.3%, respectively, and the 5-year DFS rates were 50.0, 68.0, 65.4, and 50.0%, respectively. OS and DFS were higher in group B than in groups A and D. Similarly, patients in group C were more likely to have higher OS and DFS than those in groups A and D. Meanwhile, there were no significant differences in OS and DFS between groups B and C. The multivariate analysis confirmed with high statistical significance the efficacy of complete courses of adjuvant chemotherapy, and, among them, the similar impact of 4–6/6–9 and 7–8/10–12 cycles, resulting in similar HRs vs Group A (0.52 and 0.42, respectively). Conclusions To reduce toxicity and maintain efficacy, XELOX or SOX chemotherapy regimens administered for 4–6 cycles every 3 weeks or FOLFOX regimen for 6–9 cycles every 2 weeks might be a favorable option for patients with stage II–III gastric cancer after D2 gastrectomy. Prospective multicenter clinical trials with adequate sample sizes are necessary to verify these findings.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16083-e16083
Author(s):  
Yung Lee ◽  
Yasith Samarasinghe ◽  
Michael H Lee ◽  
Luxury Thiru ◽  
Yaron Shargall ◽  
...  

e16083 Background: While neoadjuvant therapy followed by esophagectomy is the standard of care for locally advanced esophageal cancer, the role of adjuvant therapy is uncertain. As such, this review aims to analyze esophageal cancer patients who previously underwent neoadjuvant therapy followed by a curative resection (negative margins) to determine whether additional adjuvant therapy is associated with improved survival outcomes. Methods: MEDLINE, EMBASE, and CENTRAL databases were searched up to August 2020 for studies comparing patients with esophageal cancer who underwent neoadjuvant therapy and curative resection with and without adjuvant therapy. Primary outcome was overall survival (OS), and secondary outcomes were disease-free survival (DFS), locoregional recurrence, and distant recurrence at 1 and 5-years. Random effects meta-analysis was conducted where appropriate. Grading of recommendations, assessment, development, and evaluation (GRADE) was used to assess the certainty of evidence. Results: Ten studies involving 6,462 patients were included. 6,162 (95.36%) patients from 7 studies received adjuvant chemotherapy, whereas 296 (4.58%) patients from 3 studies underwent either adjuvant radiotherapy or chemoradiotherapy. When compared to patients who received neoadjuvant therapy and esophagectomy alone, adjuvant therapy groups experienced a significant overall survival benefit by 48% at 1-year (RR 0.52, 95%CI 0.41-0.65, P < 0.001, moderate certainty). This reduction in mortality was consistent at long-term 5-year follow-up (RR 0.91, 95%CI 0.87-0.96, P < 0.001, moderate certainty). Subgroup analysis on pathologic node positive patients demonstrated a consistent survival benefit at 1-year (RR 0.57, 95% CI 0.42-0.77, P < 0.001, moderate certainty) and 5-year (RR 0.89 95%CI 0.84-0.95, P < 0.001, moderate certainty). While adjuvant therapy presented no benefit for the T0-2 stage subgroup, patients with T3-4 disease experienced a significant reduction in mortality with the addition of adjuvant therapy at both 1-year (RR 0.51, 95% CI 0.41-0.63, P < 0.001, moderate certainty), and 5-years (RR 0.91, 95% CI 0.85-0.97, P = 0.005, moderate certainty). Due to incomplete reporting, the added benefit of adjuvant therapy was uncertain regarding DFS, locoregional recurrence, and distant recurrence. Conclusions: Adjuvant therapy after neoadjuvant treatment and curative esophagectomy provides improved OS at 1 and 5 years, but the benefit for DFS and locoregional/distant recurrence was uncertain due to limited reporting of these outcomes.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
R Bott ◽  
J Zylstra ◽  
M Wilkinson ◽  
W Knight ◽  
C Baker ◽  
...  

Abstract Aim  The aim of this study was to assess the survival benefit of adjuvant therapy in R0 resection patients following neo-adjuvant chemotherapy and surgery for lower oesophageal and GOJ adenocarcinoma. Background & Methods  The role of adjuvant therapy in oesophago-gastric adenocarcinoma patients treated by neo-adjuvant chemotherapy is contentious. In UK practice surgical resection margin status is often used to stratify patients into receiving adjuvant treatment. Two prospectively collected institutional databases were combined. Patients were classified by the adjuvant therapy received. Crude and adjusted Cox regression analyses compared overall and recurrence free survival according to the adjuvant treatment, stratified by resection margin status. Recurrence patterns were assessed as a secondary outcome. Results  A total of 616 patients were included (373 R0, 243 R1). In hospital mortality following surgery was 1% and these patients were excluded from analysis (n=7). In the R0 resection group 220 patients (59%) had no adjuvant treatment and 137 patients (37%) had adjuvant chemotherapy. On adjusted analysis pathological N status (p<0.0001), poor differentiation (p=0.005) and poor response to neo-adjuvant chemotherapy (p=0.001) were independently associated with poor survival. The benefit of adjuvant chemotherapy did not reach independent significance (HR 0.65 95% CI 0.40-1.06; p=0.087) compared to no treatment. However, it was observed that responders to neo-adjuvant chemotherapy (Mandard 1-3) were more likely to demonstrate a survival benefit from adjuvant chemotherapy (HR 0.42 95%CI 0.15-1.11; p=0.081) than those who are deemed to be non-responders (Mandard 4&5, HR 0.71 95%CI 0.39-1.32; p= 0.280). Conclusion  Adjuvant chemotherapy may have a survival benefit in R0 resection patients following surgery, but this is likely to be limited to patients exhibiting a good response to neo-adjuvant chemotherapy.


Surgery Today ◽  
2020 ◽  
Author(s):  
Giulio Illuminati ◽  
Rocco Pasqua ◽  
Bruno Perotti ◽  
Paolo Urciuoli ◽  
Priscilla Nardi ◽  
...  

Abstract Purpose The double-staple technique, performed as either the standard procedure or after eversion of the rectal stump, is a well-established method of performing low colorectal anastomoses following the resection of rectal cancer. Eversion of the tumor-bearing ano-rectal stump was proposed to allow the linear stapler to be fired at a safe distance of clearance from the tumor. We conducted this study to compare the results of the standard versus the eversion-modified double-staple technique. Methods The subjects of this retrospective study were 753 consecutive patients who underwent low stapled colorectal anastomosis after resection of rectal cancer. The patients were divided into two groups according to the method of anastomosis used: Group A comprised 165 patients (22%) treated with the modified eversion technique and group B comprised 588 patients (78%) treated with the standard technique. The primary endpoints of the study were postoperative mortality, surgery-related morbidity, the number of sampled lymph nodes in the mesorectum, and late disease-related survival. Results Postoperative mortality was 1.2% in group A and 1.7% in group B (p = 0.66). Postoperative morbidity was 12% in group A and 11% in group B (p = 0.75). The mean number of sampled lymph nodes in the mesorectum was 23 (range 17–27) in group A and 24 (range 19–29) in group B (p = 0.06). The 5-year disease-related survival was 73% in group A and 74% in group B (p = 0.75). Conclusion The standard and eversion-modified double-staple techniques yield comparable results.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5110-5110
Author(s):  
Haiwen Huang ◽  
Tianwen Fu ◽  
Qiangli Wang ◽  
Ting Xu ◽  
Xiaochen Chen ◽  
...  

Abstract Objectives Clinically, primary gastric diffuse large B cell lymphoma (PG-DLBCL) is not encountered commonly. The optimal treatment of PG-DLBCL remains controversial. Whether patients should receive surgical resection, Rituximab or not was most concerned about. Here we analized 83 patients with PG-DLBCL retrospectivly and evaluated the effect of surgical option and Rituximab in the treatment of PG-DLBCL. Methods From January 2009 to December 2014, 83 cases of PG-DLBCL patients in the First Affiliated Hospital of Soochow University were retrospectively studied. Forty cases received surgical resection plus chemotherapy (group A) and 43 patients underwent chemotherapy alone (group B). The operation mode is decided by the surgeon according to the patients¡¯ current condition and the chemotherapy regimens of two groups were CHOP or R-CHOP. Patients¡¯ characteristics were listed in Table 1. The main outcomes of overall survival (OS) and the progression free survival (PFS) were analized by using the Kaplan-Meier (K-M) method. Results The K-M analysis showed that the 3-year PFS and OS in group A were 66.7% and 68.4%, respectively. On the other hand, the 3-year PFS and OS of group B were 82.6%and 85.7%, respectively. There is no significant difference between the two groups. For patients received CHOP or R-CHOP, the 5-year OS were 77.7% and 78.2% (p=0.178). And the 3-year PFS were 74.9% and 75.5% (p=0.347). The difference between the two groups was not statistically significant. In group A, the 5-year PFS of R-CHOP group and CHOP group is 62.5% and 71.2% £¨p=0.747£©, the 5-year OS of R-CHOP group and CHOP group is 64.2% and 73.6% (p=0.853). In group B, the 5-year PFS of R-CHOP group and CHOP group is 83.4% and 81.8% £¨p=0.706£©, the 5-year OS of R-CHOP group and CHOP group is 85.7% and 83.5% (p=0.753). The univariate analyses indicated that age and lactate dehydrogenase (LDH) level were related to prognosis. Multivariate analysis of prognostic factors with a Cox model showed that IPI was the only independent prognostic factor. Conclusions This study shows that PG-DLBCL patients have a similar long-term survival rate when adopted surgery plus chemotherapy. Therefore, resection of the primary tumor before systemic chemotherapy does not improve the survival of the patients with PG-DLBCL. At the same time, the addition of Rituximab to chemotherapy doesn¡¯t make difference for the survival of PG-DLBCL. More prospective clinical trials about the effect of surgical operation and rituximab are needed to confirm the results of our study. Table 1. Patients¡¯ baseline characteristics Patients £¨%£© P value With surgical resection(Group A, n£½40£© Without chemotherapy (Group B, n £½ 43 £© Gender Male 19£¨47.5%£© 24£¨55.8%£© 0.449 Female 21£¨52.5%£© 19£¨44.2%£© Age ¡Ü60 15£¨37.5%£© 22£¨51.2%£© 0.211 £¾60 25£¨62.5%£© 21£¨48.8%£© Ann Arbor Stage I/II 13£¨32.5%£© 7£¨16.3%£© 0.084 Stage III/IV 27£¨67.5%£© 36£¨83.7%£© ECOG £¼2 19£¨47.5%£© 22£¨51.2%£© 0.739 ¡Ý2 21£¨52.5%£© 21£¨48.8%£© Treatment plan R-CHOP 23£¨57.5%£© 24£¨55.8%£© 0.887 CHOP 17£¨42.5%£© 19£¨44.2%£© LDH ¡Ü245 24£¨60.0%£© 27£¨62.8%£© 0.794 £¾245 16£¨40.0%£© 16£¨37.2%£© IPI ¡Ü2 13£¨32.5%£© 15£¨34.9%£© 0.818 £¾2 27£¨67.5%£© 28£¨65.1%£© ECOG: Eastern Cooperative Oncology Group; CHOP: cyclophosphamide, doxorubicin, vincristine, prednisone; R-CHOP: rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; LDH: lactate dehydrogenase Disclosures No relevant conflicts of interest to declare.


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