Norwegian Patients with Colon Cancer Start Their Adjuvant Therapy Too Late 27
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ORIGINAL ARTICLE Original article Norwegian patients with colon cancer start their adjuvant therapy too late 27 – 31 BACKGROUND For patients with colon cancer who are to receive adjuvant chemotherapy Frank Olsen according to national guidelines, such therapy must be initiated no more than 4 – 6 weeks Bård Uleberg Centre for Clinical Documentation and Evaluation after the surgical intervention. We wished to investigate whether these guidelines are being (SKDE) complied with. We also wished to see whether the type of surgery (open or laparoscopic) had Northern Norway Regional Health Authority any effect on the time elapsing before initiation of adjuvant therapy. Bjarne Koster Jacobsen Centre for Clinical Documentation and Evaluation MATERIAL AND METHOD The material includes 1 132 patients who had undergone surgery (SKDE) for colon cancer in the period 2008 – 2013 and who received adjuvant chemotherapy. Surgical Northern Norway Regional Health Authority treatment and adjuvant chemotherapy are defined through diagnosis and procedural codes and in the Norwegian Patient Register for the period 2008 – 2013. Department of Community Medicine UiT– Arctic University of Norway RESULTS On average, 44.7 days passed after the surgical intervention before the patients Lise Balteskard commenced their adjuvant chemotherapy. For 49 % of the patients, the adjuvant therapy was [email protected] not initiated within the six-week deadline. Patients who had undergone laparoscopic surgery Centre for Clinical Documentation and Evaluation were hospitalised for shorter periods (6.5 days versus 10.7 days) and had fewer complica- (SKDE) Northern Norway Regional Health Authority tions (7.6 % versus 16.4 %) when compared to patients who had undergone open surgery, yet still failed to start their adjuvant therapy correspondingly earlier. INTERPRETATION Measures should be taken to improve quality, thus ensuring that the guidelines are complied with and that patients start their required adjuvant therapy earlier. MAIN MESSAGE For those who have undergone laparoscopic surgery, it ought to be simple to reap the gains One-half of all patients who need adjuvant from shorter hospitalisation periods and fewer complications in the form of a more rapid chemotherapy for colon cancer start their initiation of adjuvant therapy. treatment later than is recommended by national guidelines. Patients who have undergone laparoscopic National recommendations for treatment of We wished to investigate whether the surgery have shorter hospitalisation periods colorectal cancer have existed in Norway national guidelines with regard to the time of and fewer complications, but still fail to since the early 1990s. According to these initiation of adjuvant therapy were followed start their adjuvant therapy correspondingly national guidelines, patients with colon can- up in Norwegian hospital trusts, and to see cer with a high risk of relapse must receive whether the type of surgery was related to earlier than those who have undergone open adjuvant chemotherapy (1). Such treatment is any differences in the time that elapsed surgery. normally provided over a period of six before initiation of adjuvant therapy. months to patients under 75 years, and the guidelines stipulate that it should start within Material and method 4 – 6 weeks (28 – 42 days) after surgery. This study is part of the research project The optimal time for initiation of adjuvant «Analyses of patient pathways», which has chemotherapy after surgery for colon cancer obtained a licence from the Norwegian Data has not been established by randomised cli- Protection Authority and has been exempted nical trials. There is nevertheless an inter- from the duty of confidentiality by the national clinical consensus that treatment Regional Committee for Medical and Health ought to start within 4 – 8 weeks after sur- Research Ethics. The licence grants access gery, and that providing this treatment after to personally identifiable data from the Nor- three months is not appropriate, since the wegian Patient Register, which has provided objective is to eliminate any circulating information on patients treated in Norwe- malignant cells (2). Even though the natio- gian hospitals in the period 2008 – 2013. nal guidelines in this area have a low level of Encrypted patient serial numbers permit evidence (Level D), this is no reason for descriptions of patient pathways that every hospital trust to follow its own prac- involve multiple hospitals over several tice. If so, this should be justified in every years. In addition to selected patient infor- individual case. A meta-analysis from 2011 mation, such as place of residence and gen- indicates that relative survival is reduced by der, the licence grants access to certain 14 % for each week adjuvant therapy is administrative and medical data, including delayed (3). An analysis from the Danish institutions, treatment level and diagnosis colorectal cancer registry shows a reduction codes (ICD-10), as well as procedural codes in the total survival rate if the chemotherapy (Norwegian classification of medical proce- is initiated more than 55 days after surgery dures (NCMP) and the Nordic classification (4). of surgical procedures (NCSP)). Tidsskr Nor Legeforen nr. 1, 2016; 136: 27 – 31 27 ORIGINAL ARTICLE estimated date of surgery and one of two Patients with cancer diagnosis and surgery during the same hospitalisation period, 2008–13: treatment patterns were discovered (1 132 pa- 12 356 patients tients): • Up to 12 treatments received over a period of 210 days, with a minimum interval of two weeks between each treatment (5- Excluded: patients with secondary neoplasms within 90 days after surgery: fluorouracil and calcium folinate combi- ned with oxaliplatin). 1 979 patients • Up to eight treatments received over a period of 210 days, starting every three weeks (capecitabine/oxaliplatin) Patients with a curative intention: Patients who had suffered complications or 10 377 patients had undergone reoperations were identified with a diagnosis code for complications (T81.0 – 81.9, T88.8, Y83.2) or a procedure code for reoperation (JW*) during the same Excluded (in sequence): hospitalisation period as the primary surgery Patients older than 75 years: 4 770 patients or within 30 days after the estimated date of Patients with surgery after 1 March 2013: 802 patients the surgical procedure. A total of 158 pa- Patients not receiving adjuvant therapy: 3 673 patients tients were identified as having suffered complications. Total excluded: 9 245 patients Statistical method The analyses were undertaken in the statis- tics software application SAS (SAS Insti- Patients with adjuvant therapy: Open surgery: 816 patients tute, Cary, N.C.). These analyses include the 1 132 patients Laparoscopic surgery: 316 patients entire population, not merely a sample, and no p-values are therefore reported for diffe- rences between groups and categories. Figure 1 Patient selection from the Norwegian Patient Register Regression analysis was used to analyse the associations between the number of days elapsing between surgery and the initiation Study population colon cancer and were not coded for secon- of adjuvant therapy, hospitalisation period The sample for our study includes patients dary neoplasms (C77.0, C77.1, C77.3, C78* and age. who have undergone surgery for colon can- or C79*) within 90 days after the estimated cer in the period 2008 – 2013, defined date of surgery were assumed to have a limi- Results through the diagnosis code for colon cancer ted illness requiring therapy with a curative Altogether 1 132 patients (Figure 1) recei- (C18) and codes for surgical procedures that intention, and thus to be available for adju- ved adjuvant chemotherapy, 52 % of whom indicate removal of parts or the whole of the vant therapy (10 377 patients). were women. The average age was 62.7 large intestine. To ensure a sufficiently long follow-up years, with only a minor difference in aver- Open surgery is defined by the procedural period to be able to assess whether chemo- age age between men and women. Nor were codes JFB20, JFB30, JFB33, JFB40, JFB43, therapy had been administered for six there any major differences in the average JFB46, JFB50, JFB60, JFB63, JFB96, JFH00, months after the primary surgical treatment, age of persons who had undergone open sur- JFH10 and JFH96. Laparoscopic surgery is we included only patients with an estimated gery and laparoscopic surgery respectively. defined by the procedural codes JFB21, date of surgery earlier than ten months before Altogether 14 % of the patients had sustained JFB31, JFB34, JFB41, JFB44, JFB47, JFB51, the end of the data set (i.e. admission date complications or undergone reoperations. JFB61, JFB64, JFB97, JFH01 and JFH11. before 1 March 2013) in our patient sample. There were only minor differences between The date of admission to hospital for sur- Patients older than 75 years are normally not men and women with regard to the propor- gery plus two days was set as the date of the considered for adjuvant therapy for colon tion of complications. The proportion of surgery, since we did not have access to the cancer and were excluded (Figure 1). Pa- complications among those who had actual date of the intervention. tients who were not coded with C18 as a undergone open surgery was more than Patients who had undergone relevant sur- diagnosis in the period while the adjuvant double compared to patients who had under- gery to the colon and during the same hospi- chemotherapy