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Archived Comments for: Incidence of breast cancer in Italy: mastectomies and quadrantectomies performed between 2000 and 2005

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  1. Trend assesment by comparison with a Cancer Registry

    Paolo Contiero, National Cancer Institute of Milan

    5 July 2009

    I have carefully read the paper, interesting because present a method to estimates breast cancer incidence, a so important topic for health service planning and primary prevention researches.
    In my opinion, the weakness of this paper is the lack of a gold standard by which validate the method and its results. This could lead to the introduction of some bias in the estimates that are not possible to detect easily.
    By this notes I show some data from the Cancer Registry of Varese and the hospital discharges of the same area.
    The Cancer Registry of Varese began its activity in 1976 and its data was included in the last four editions of the Cancer Incidence in Five Continents.
    The Cancer Registry data are linked with the hospital discharge (SDO), pathology report and death certificate files, all of these sources contain personal data.
    The availability of the hospital discharge file gave me the possibility to evaluate the algorithm proposed versus a gold standard such as a Cancer Registry.
    A Cancer Registry could be considered a gold standard because: i) it contains validated data, i.e. true cases and not false positives or not accurate diagnosis ii) it contains virtually all the cases of the target population, without selection related to diagnosis or treatment, as could be using surgical procedure to identify cases iii) it register personal data, avoiding the bias of counting twice or more patients with more that one SDO iv) it can correctly classify incident and prevalent cases.

    The comparison considers four years of incidence, from 2000 to 2003.
    I have applied the algorithm by Giordano to the SDO of the residents of Varese province, from 1/1/2000 to 31/12/2003.
    I have linked those records with the Varese Cancer Registry.
    The number of cases registered by the Registry, from year 2000 to 2003 are respectively:
    721 , 729 , 731 , 739, with an increase in 2003 vs 2000 of 2.5 %. The algorithm identifies for the same years the following cases (% of lost cases): 653 (-9.4 %) , 674 (-7.5 %), 714 (-2.3 %), 704 (-4.7 %), with an increase in 2003 vs 2000 of + 7.8 %
    The cases discarded by the registry and identified by the algorithm (390) were prevalent cases or cases with a diagnosis different from malignant neoplasm of breast. The cases not caught by the algorithm but identified by the Registry (565) were cases that have on the hospital discharges a diagnosis different from malignant neoplasm of breast or cases with none or different surgical procedures respect to those used by the algorithm.


    The algorithm described in the paper produce an underestimate of the real number of cases that varies from 4.7 to 9.4 %. This is the result of two bias that act in two different directions. Prevalent cases inflates incidence meanwhile cases excluded by the algorithm for diagnostic or intervention codes produce a bias in the opposite direction.
    The increase in the number of cases computed by the algorithm on the hospital discharges is 2.6 % per year on Varese data, similar to the data reported in table 4 of the paper by Giordano, meanwhile the Varese Cancer Registry reports an increase per year of 0.8 %.
    By this comparison, it seems the increase computed by the algorithm doesn’t correspond to a real increase in the number of cases but that it depends only by the increasing use of surgical procedures.

    Competing interests

    I have no competing interest


    Prisco Piscitelli, CROM

    20 July 2009

    Although Cancer Registries remain the gold standard for epidemiologic evaluation of tumors, unfortunately they are not currently available in all Italian provinces. Therefore, in order to evaluate the incidence of neoplastic lesions at national level (as declared in its publications), the Italian Association of Cancer Registries must use other data sources (such as mortality rates provided by the National Instiute for Statistics, ISTAT) or refer to average values determined within the few existing registries (actually 70% of Italian population is not being covered by cancer registries). This means that national data concerning the incidence of cancers in Italy are the result of average estimations or statistical models and do not reflect a real "count" of overall cases. On the other hand, there is a huge National database which is available for researchers: the National hospitalization records database (SDO), which has already been validated in many internation publications, being also uses by Piemonte Region in its cancer surveillance programs (with good published results).

    Therefore, authors of the article tried to use the National hospitalization database (SDO) as a potential datasource for determining the incidence of such an impactful tumour as breast cancer.

    Concerning the SDO database, it must be pointed out that authors have excluded 1999 from the analysis because the Ministry of Health - at our knowledge - can provide complete archives since year 2000. However, if some hospital records would have not been sent to the central database, this could have produced only an underestimation and not an overestimation of the phenomenon.

    While examining SDO database, authors DID NOT analyzed "diagnosis of breast cancer" because it would have produced too many bias due to the double count of the same patients hospitalized twice or more times with the same "major diagnosis". Authors have rather decided to analyze the number of surgical interventions, namely quadrantectomies and mastectomies in order to "count" the new breast cancer cases because:

    - these procedures are used only in case of breast cancer;

    - the risk of "double count" of the same patient is low because number of patients who undergo mastectomy or quadrantectomy twince in the same year is very very low, as assessed in a preliminary survey by the surgeons involved in the study;

    - the risk of including prevalent cases in the "count" is also low because the time elapsing between new diagnosis of brest cancer and surgical intervention do not exceed 30 days according to the US and European guidelines; furthermore, relapses of the disease are mostly detected after 5 and even 10 years from the intervention (therefore outside of the range of the study period). If looking at the literature, the risk of relapses after mastectomy is 5-10% at 10 years, while the risk of relapses after quadrantectomy is 10-15% at 10 years; only breast relapsing leasions are eligible for new surgical procedures (actually metastases are treated in other ways), and only lesions relapsig after quadrantectomy are treated surgically with a new mastectomy.

    On the other hand, even though authors have declared in methodological section the risk of a small overestimation of new breast cancer cases, the "count" provided in the article CANNOT consider all the breast cancers which are not treated by surgery (about 10% of new breast tumour diagnoses) and the small proportion of "in situ carcinomas" which are not treated with quadrantectomy but only with tumorectomy: so there is a wide underestimation preliminary effect to be taken into account, so that the surprising results of the study could be also regarded as conservative ! Furthermore, there's no risk of having included benign lesions because authors have counted MAJOR BREAST SURGICAL PROCEDURES (quadrantectomies and mastectomies) and have decided to exclude tumorectomies and excision biopsis from the analysis.

    Concerning the comment of the colleague Paolo Contiero, who did a very good job in the right experimental perspective, it seems that he has analyzed SDO database of Varese province (where a cancer registry sortunately exists)looking for major diagnosis of breast cancer. On the contrary, authors of the article has examined only major breast surgical procedures, namely mastectomy (ICD9-CM code 85.4) and quadrantecomy (code 85.22), therefore resulting in an overestimation due to double count of the same patient. However, authors may also hypotize that data of Varese province could result in a small difference between the Cancer Registry and the SDO database (actually 2% as reported by Dr. Contiero), but the objective of the article was not to compare SDO database with Cancer Registries datasets, because there are no problem in assessing the phenomenon in those provinces where a Registry already exists.
    Authors' aim was actually to overcome the existimations produced when computing incidence at national level by the methods currently used (average calculations and statistical models based on ISTAT mortality rates). In this perspective, and until cancer registries will not cover all the Country, SDO database could be a valuable opportunity to be successfully used as already has been done in Piemonte Region.

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    Competing interests

    I'm one of the author of the article