Adjuvant chemotherapy in colorectal cancer: A joint analysis of randomised trials by the Nordic Gastrointestinal Tumour Adjuvant Therapy Group

549 Background: Laparoscopic (LS) and robotic surgery (RS) for colorectal cancer provides a new perspective of the deep pelvis. Our goal was to identify the role of LS and RS for patients with sigmoid and rectal cancer. Methods: We retrospectively analyzed 53 patients treated from 2007-2012. Resection type, previous surgery, neoadjuvant and adjuvant therapy, timing of surgery, lymph nodes (LN) harvested, estimated blood loss (EBL), operative time (OT), complications, and pathology were reviewed. Results: Of 53 patients, 32 underwent LS, and 18 RS. There were 47 patients with adenocarcinoma, 5 with unresectable polyps and 1 with anal melanoma. 62% of patients underwent a recto-sigmoid resection, 23% rectal, and 8% sigmoid. 32% had prior surgery. Neoadjuvant treatment (NAT) was initiated in 31 patients; 3 received chemotherapy without radiation, and 1 short course radiation. An average of 12.8 and 8.4 LN were harvested in the LS and RS groups respectively, with a mean of 9.9 LN after NAT, and 13.9 without. EBL was 155ml (20-650) with LS and 178ml (25-600) with RS. 3 LS cases were converted to an open procedure. Median OT was 270 and 302 minutes for LS and RS groups. Using the Clavien grading system, 12 patients had grade 1-2 complications, 5 grade 3, and 2 grade 4’s within 30 days. Radial margins were positive in 2 patients; one received NAT for a fungating anal adenocarcinoma, and the other had chemotherapy alone. One patient had a positive proximal margin with no prior therapy. Rate of complete pathological response (pCR) was 35%, and 71% were down staged. The mean interval between completion of NAT and resection was 8 weeks (range 4-12), and surgery to adjuvant therapy was 8 weeks (range 4-22). Conclusions: LS and RS surgery for colorectal cancer can be safely performed in conjunction with neoadjuvant and/or adjuvant chemotherapy. NAT should not preclude adoption of these techniques, as we achieved a 35% pCR with minimal operative morbidity allowing patients to proceed to adjuvant chemotherapy in a timely fashion. [Table: see text]

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Assessing the validity of using claims data compared to medical chart reviews for measuring care quality in Japan.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.30_suppl.264 ◽

2014 ◽

Vol 32 (30_suppl) ◽

pp. 264-264

Author(s):

Nana Nakamoto ◽

Fumiaki Nakamura ◽

Takahiro Higashi ◽

Momoko Iwamoto ◽

Asuka Amano ◽

...

Keyword(s):

Colorectal Cancer ◽

Gastric Cancer ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Cancer Patients ◽

Medical Record ◽

Claims Data ◽

Care Quality ◽

Quality Performance ◽

Gastric Cancer Patients

264 Background: Health insurance claims data have been used extensively as a less labor-intensive method of collecting data than medical record reviews, which are the preferred source of data collection in most medical studies. Although recent reports have raised questions about its validity of use in measuring care quality, validity of using claims data may differ by health systems and should therefore be assessed by country. We aimed to test the validity of using claims data in Japan by comparing quality performance scores obtained from claims data to those derived from medical record reviews. Methods: We reviewed medical records from Apr 2013 to Apr 2014 of gastric and colorectal cancer patients who were diagnosed in 2011 from 4 cancer care hospitals in Okinawa. We calculated the proportion of patients who received adjuvant chemotherapy for gastric and colorectal cancer using claims data, and compared the results with those obtained from medical record reviews. Chart reviews were performed by certified tumor registrars. We used kappa coefficients to measure the level of agreement between claims data and medical record reviews. Results: Analysis using claims data resulted in 14 Stage II and III gastric cancer patients who had undergone surgery, with 50% receiving adjuvant chemotherapy; whereas medical record reviews resulted in 19 patients, 94.7% of whom either received or had a clinically valid rationale for not undergoing adjuvant therapy. For colorectal patients, claims data resulted in 48.5% of 68 surgical stage III colorectal patients receiving adjuvant therapy, compared to 74.4% of 78 patients using medical record reviews who either received adjuvant therapy or had a valid reason for not undergoing therapy. Agreement between claims data and chart reviews was low (kappa=0.14) for gastric cancer, but fair (kappa =0.37) for colorectal cancer. Conclusions: Our analysis showed that use of claims data may greatly underestimate quality performance measures if they are not compensated by medical record reviews. Claims data alone cannot capture a large proportion of patients who either choose not to, or has a clinically valid reason for not undergoing standard care.

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Use of Adjuvant Chemotherapy and Radiation Therapy for Colorectal Cancer in a Population-Based Cohort

Journal of Clinical Oncology ◽

10.1200/jco.2003.06.178 ◽

2003 ◽

Vol 21 (7) ◽

pp. 1293-1300 ◽

Cited By ~ 219

Author(s):

John Z. Ayanian ◽

Alan M. Zaslavsky ◽

Charles S. Fuchs ◽

Edward Guadagnoli ◽

Cynthia M. Creech ◽

...

Keyword(s):

Colorectal Cancer ◽

Rectal Cancer ◽

Colon Cancer ◽

Radiation Therapy ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Population Based ◽

Stage Ii ◽

Stage Iii Colon Cancer ◽

Adjuvant Therapies

Purpose: Randomized trials have demonstrated that adjuvant chemotherapy improves survival for patients with stage III colon cancer and that chemotherapy combined with radiation therapy improves survival for patients with stage II or III rectal cancer. This population-based study was designed to assess use of these treatments in clinical practice. Patients and Methods: From the California Cancer Registry, we identified all patients diagnosed during 1996 to 1997 with stage III colon cancer (n = 1,422) and stage II or III rectal cancer (n = 534) in 22 northern California counties. To supplement registry data on adjuvant therapies and ascertain reasons they were not used, we surveyed physicians or reviewed office records for 1,449 patients (74%). Results: Chemotherapy rates varied widely by age from 88% (age < 55 years) to 11% (age ≥ 85 years), and radiation therapy varied similarly. Adjusting for demographic, clinical, and hospital characteristics, chemotherapy was used less often among older and unmarried patients, and radiation therapy was used less often among older patients, black patients, and those initially treated in low-volume hospitals. Adjusted rates of chemotherapy varied significantly (P < .01) among individual hospitals: 79% and 51%, respectively, at one SD above and below average (67%). Physicians’ reasons for not providing adjuvant therapy included patient refusal (30% for chemotherapy, 22% for radiation therapy), comorbid illness (22% and 14%, respectively), or lack of clinical indication (22% and 45%, respectively). Conclusion: Use of adjuvant therapy for colorectal cancer varies substantially by age, race, marital status, hospital volume, and individual hospital, indicating opportunities to improve care. With enhanced data on adjuvant therapies, population-based registries could become a valuable resource for monitoring the quality of cancer care.

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Capecitabine maintenance therapy after adjuvant chemotherapy of FOLFOX (or XELOX) in patients with stage IIIC or R0 resected stage IV colorectal cancer (CAMCO study).

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.tps781 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. TPS781-TPS781

Author(s):

Jiayu Ling ◽

Wenjing Wang ◽

Shanshan Li ◽

Yue Cai ◽

Huabin Hu ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Maintenance Therapy ◽

Stage Iv ◽

Stage Iiic ◽

Resected Stage ◽

Clinical Trial Information

TPS781 Background: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer (CRC). Treatment with current strategies, however, recurrent rate is high for stage IIIc or R0 resected stage IV CRC (high risk-CRC). For some other maglinancies with high risk of recurrence, such as gastric cancer or high-risk gastrointestinal stromal tumor, longer period of postoperative chemotherapy was applied. The effectiveness of maintenance therapy following standard adjuvant chemotherapy in high risk-CRC has not been verified in clinical trial. Capecitabine is is an orally-administered chemotherapeutic agent used in the treatment of CRC, either as neoadjuvant therapy with radiation, adjuvant therapy or for metastatic cases. This study is exploring the efficacy and safety of strategy of surgical resection and adjuvant chemotherapy followed by maintenance capecitabine for stage IIIC or R0 resected stage IV CRC. Methods: The study was designed as an open-label phase II trial with 200 patients assigned to two thearapy group: experimental arm A (Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months + oral capecitabine 1000mg/m2 twice daily days1-14 every 3 weeks for 12 months maintenance) or standard arm B (Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months + observation). Eligibility included patients of 18-80 years of age, diagnosis of adenocarcinoma of the colon or rectum, received curative resection when diagnosed, with postoperative stage of IIIC OR IV(R0 resected), PS 0-1 and adequate organ function. Doses were modified for hand-foot syndrome, diarrhea and other grade 3 toxicities. The primary aim is to evaluate the 3 year disease free survival of the patients. Secondary aims inclued overall survival, safety, quality of life and an assessment of predictive molecular markers of maintenance strategy. After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3rd-5th years. This study is now open to accrual in The Sixth Affiliated Hospital of Sun Yat-sen University. Clinical trial information: NCT01880658. Clinical trial information: NCT01880658.

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Retrospective analysis of outcomes in patients with non metastatic cholangiocarcinoma: A single network experience.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15643 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15643-e15643

Author(s):

Jyothika Mamadgi ◽

Kristina Lundeen ◽

Shaakir Hasan ◽

Sunita Patruni ◽

Ahmed Khattab ◽

...

Keyword(s):

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Adjuvant Treatment ◽

Therapy Group ◽

Progression Free Survival ◽

Distant Recurrence ◽

Treatment Modalities ◽

Group 3 ◽

Group 2 ◽

Group 1

e15643 Background: Biliary tract cancers are rare cancers with an annual incidence of about 8,000. In resected non-metastatic BTCs (NM-BTCs), cure rates decrease significantly due to local and distant recurrence. However, guidelines to use adjuvant therapies are not well established due to the lack of well-structured phase three randomized trials, given the rarity of the disease. We present a retrospective study analyzing outcomes of NM-BTCs managed within Allegheny Health Network (AHN) with specific focus on patients who underwent resection and received different adjuvant treatment modalities. Methods: Data of all patients with NM-BTCs treated at AHN from January 2012 to December 2017 was collected and outcomes analyzed for patients treated with surgery vs no surgery We then sub-stratified the patients who received surgery into three groups based on the modality of adjuvant therapy. Group 1 included patients with no additional therapy , Group 2 with adjuvant chemotherapy and Group 3 with adjuvant chemotherapy+radiation. We compared Mean Progression-Free Survival (PFS) and Overall Survival (OS) in these three groups. Results: Of the 59 NM-BTCs treated at AHN, 32(52.4%) underwent surgery. The OS for surgical vs non-surgically treated patients was 23 vs 17 months (p = 0.008) and PFS 26 vs 19 months (P = 0.06) respectively. Of the resected –patients, PFS for patients in Group1 vs Group2 vs Group3 was 16 vs 21 vs 34 months (pooled P = 0.05) and OS was 19 vs 22 vs 19 months respectively (pooled P = 0.5). PFS for patients in Group1 vs Group (2+3),i.e, patients treated surgery only vs surgery+ any adjuvant treatment was 16 vs 28 months (P = 0.1), OS was 19 vs 22 months (P = 0.7)respectively. PFS in patients in Group 3 vs Group (1+2),i.e, patients treated with adjuvant chemotherapy+radiation vs others was 34 vs 19 months. (p = 0.0183) respectively. Conclusions: This analysis revealed a statistically significant improvement in OS in patients with NM-BTCs who received surgery. There was a trend towards improvement in PFS/OS in patients who received adjuvant therapy, though not statistically-significant. Use of adjuvant chemotherapy+radiation resulted in statistically significant improvements in PFS as compared to other treatment modalities.

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Recurrence Risk after Radical Colorectal Cancer Surgery—Less Than before, But How High Is It?

Cancers ◽

10.3390/cancers12113308 ◽

2020 ◽

Vol 12 (11) ◽

pp. 3308 ◽

Cited By ~ 1

Author(s):

Erik Osterman ◽

Klara Hammarström ◽

Israa Imam ◽

Emerik Osterlund ◽

Tobias Sjöblom ◽

...

Keyword(s):

Colorectal Cancer ◽

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Adjuvant Treatment ◽

Recurrence Risk ◽

Accurate Estimate ◽

Tumour Cells ◽

Recurrence Rates ◽

Colorectal Cancer Surgery

Adjuvant chemotherapy aims at eradicating tumour cells sometimes present after radical surgery for a colorectal cancer (CRC) and thereby diminish the recurrence rate and prolong time to recurrence (TTR). Remaining tumour cells will lead to recurrent disease that is usually fatal. Adjuvant therapy is administered based upon the estimated recurrence risk, which in turn defines the need for this treatment. This systematic overview aims at describing whether the need has decreased since trials showing that adjuvant chemotherapy provides benefits in colon cancer were performed decades ago. Thanks to other improvements than the administration of adjuvant chemotherapy, such as better staging, improved surgery, the use of radiotherapy and more careful pathology, recurrence risks have decreased. Methodological difficulties including intertrial comparisons decades apart and the present selective use of adjuvant therapy prevent an accurate estimate of the magnitude of the decreased need. Furthermore, most trials do not report recurrence rates or TTR, only disease-free and overall survival (DFS/OS). Fewer colon cancer patients, particularly in stage II but also in stage III, today display a sufficient need for adjuvant treatment considering the burden of treatment, especially when oxaliplatin is added. In rectal cancer, neo-adjuvant treatment will be increasingly used, diminishing the need for adjuvant treatment.

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Analysis of the efficacy of CIK therapy in adjuvant treatment of colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e15022 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e15022-e15022

Author(s):

Rui Guo ◽

Haiyan Piao ◽

Gang Shi ◽

Guirong Zhang ◽

Rui Zhang

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Adjuvant Therapy ◽

Therapy Group ◽

Survival Rates ◽

Group Versus ◽

Infusion Therapy ◽

Cancer Hospital ◽

Significant Difference ◽

Cik Cell

e15022 Background: In the past decade, cell-based immunotherapy has been reported to improve the clinical outcomes by altering tumor immune responses, improving prognosis and overall survival rates in cancer patients.This retrospective study aimed to evaluate the efficacy of cytokine-induced killer (CIK) cell infusion as an adjuvant therapy in patients with colorectal cancer. Methods: A total of 370 patients with colorectal cancer admitted to Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Insititute from March 2013 to April 2015 were retrospectively analyzed.All patients were treated with surgery for primary lesions, and then adjuvant chemotherapy was determined according to the guidelines. Among these patients, 201 patients received CIK therapy (CIK group),while the other 169 patients who had similar demographic and clinical characteristics did not receive a CIK cell infusion therapy (non-CIK group). Then we followed up these patients. Data were analyzed by Kaplan-Meier. Results: Our results showed that the 1,3,5-year overall survival (OS) rate for the CIK group versus the non-CIK group was 98.46 versus 93.61%, 85.4 versus 71.61%, 79.39 versus 67.9%, respectively. The OS was significantly longer in CIK group than in non-CIK group (P = 0.009). Meanwell, the OS of stage II and III colorectal cancer was significant in CIK group than in non-CIK group (P = 0.02 and 0.02). But the OS was not significant in Stage I and IV colorectal cancer (P = 0.347 and 0.285). We analyzed the patients between chemotherapy plus CIK therapy group and chemotherapy only group. We find that the OS has significant difference in two groups (P < 0.001). Conclusions: CIK therapy can improve the efficacy of adjuvant therapy in patients with colorectal cancer. But multicenter, large-sample randomized controlled trials are still needed to confirm it.

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Systemic inflammation, adjuvant chemotherapy, and survival in stage III colorectal cancer: Results from the ScotScan Colorectal Cancer Collaborative.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.228 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 228-228

Author(s):

James Hugh Park ◽

Anniken Jorlo Fuglestad ◽

Anne Helene Kostner ◽

Agata Oliwa ◽

Campbell SD Roxburgh ◽

...

Keyword(s):

Colorectal Cancer ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Predictive Biomarker ◽

Stage Iii ◽

C Reactive Protein ◽

Cancer Specific Survival ◽

Reactive Protein ◽

Chemotherapy Regime ◽

The Relationship

228 Background: The systemic inflammatory response (SIR) is a poor prognostic marker in patients with colorectal cancer (CRC), and predicts poor outcome following adjuvant chemotherapy. Whether this may be influenced by chemotherapy regime is not known. The present study examined the relationship between the pre-operative SIR, adjuvant therapy regime, and survival of patients with stage III CRC in the ScotScan cohort. Methods: Patients with stage III CRC in Scotland (1997-2015, n= 317) and Norway (2000-17, n= 312) were included. The pre-operative SIR was measured using C-reactive protein (CRP≤10mg/L or > 10mg/L). Adjuvant status was categorised as none, 5-fluorouracil-only (5FU or capecitabine), or oxaliplatin-combination (Ox). Relationship with 3 year overall (OS) and cancer-specific survival (CSS) was examined. Results: Rates of Ox were comparable between cohorts (Scotland – 26% vs. Norway 28%), although more patients from Norway received single 5FU (4% vs. 19%, P= 0.005). 36% of each cohort were systemically inflamed. Ox was associated with superior OS (90%) and CSS (92%) when compared to 5FU (77% and 84%) and no therapy (61% and 72%, both P< 0.001). Stratified by SIR, patients with CRP≤10mg/L receiving Ox or 5FU had comparable 3yr OS greater than those receiving none (90% vs. 88% vs. 67%), whereas those with CRP > 10mg/L receiving Ox had superior survival than those receiving 5FU or no therapy (89% vs. 64% vs. 53%, P-for interaction = 0.101). Results were similar for CSS (CRP≤10mg/L: 91% vs. 94% vs. 79%; CRP > 10mg/L: 94% vs. 72% vs. 62%, P-for interaction= 0.01). Although patients receiving Ox were younger and less comorbid, both use of Ox and SIR remained independently associated with OS and CSS. Conclusions: Although selection bias in the choice of adjuvant therapy may confound analysis, this study suggests the SIR may aid in determining response to adjuvant therapy. Whereas non-inflamed patients with stage III CRC may benefit from single 5FU, those with an elevated SIR may benefit greater from more intensive, Ox-based regimes. These results remain to be validated, however support the use of the SIR as a prognostic and predictive biomarker in patients with stage III CRC.

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Adjuvant chemotherapy in colorectal cancer with high-dose leucovorin and fluorouracil: impact on disease-free survival and overall survival.

Journal of Clinical Oncology ◽

10.1200/jco.1997.15.6.2432 ◽

1997 ◽

Vol 15 (6) ◽

pp. 2432-2441 ◽

Cited By ~ 46

Author(s):

A Zaniboni

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Clinical Trials ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Randomized Trials ◽

Disease Free Survival ◽

High Dose ◽

Free Survival ◽

Disease Free

PURPOSE The rationale for using adjuvant chemotherapy in colorectal cancer is to achieve better disease control and thus reduce the high rates of tumor recurrence and mortality in patients who undergo curative surgery. The current literature, including relevant abstracts, on clinical trials of fluorouracil (5-FU) in combination with high-dose leucovorin as adjuvant chemotherapy for colorectal cancer is reviewed. The intent is not to present new data, but to present the reader with a broad perspective and larger patient experience on which to base well-reasoned treatment decisions. DESIGN Published clinical trials and abstracts presented at the 1996 American Society of Clinical Oncology (ASCO) meeting that assessed 5-FU in combination with high-dose leucovorin as adjuvant chemotherapy for colorectal cancer were surveyed. End points of interest were disease-free survival (DFS), overall survival, and toxicity. RESULTS In randomized trials that used high-dose leucovorin at doses that ranged from daily-times-five 200 mg/m2 to weekly 500 mg/m2 in combination with 5-FU, significant improvements in both DFS and overall survival were observed over surgery alone (control). In patients treated with high-dose leucovorin/5-FU, DFS rates ranged from 71% to 77% compared with control (58% to 64%). A similar trend was seen in overall survival, with a range of 75% to 84% compared with control (63% to 77%). Toxicities observed for high-dose leucovorin administered on a weekly or daily-times-five schedule were diarrhea, stomatitis, myelosuppression, and nausea. CONCLUSION Overall, the results of these randomized trials support the use of high-dose leucovorin/5-FU as adjuvant therapy for colorectal cancer. Longer follow-up studies are needed to compare the benefits of these different regimens in terms of survival and to characterize adverse effects, especially those that may not be immediately evident. Adjuvant therapy with high-dose leucovorin/5-FU is an effective regimen that is well tolerated by many patients with colorectal cancer.

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