Elisa Piovano

Is there a role for postoperative treatment in patients with stage Ib2–IIb cervical cancer treated with neo-adjuvant chemotherapy and radical surgery? An Italian multicenter retrospective study

PURPOSE Neoadjuvant chemotherapy [NACT] followed by radical hysterectomy is an alternative therapeutic option to concurrent chemotherapy-radiotherapy for locally advanced cervical cancer. However there are very few data about the effectiveness of any post-operative treatment in this clinical setting. The purpose of this study was to correlate the patterns of recurrence and the clinical outcomes of cervical cancer patients who received NACT, with postoperative adjuvant treatment. PATIENTS AND METHODS This retrospective multicenter study included 333 patients with FIGO stage Ib2-IIb cervical cancer who underwent platinum-based NACT followed by radical surgery. Pathological responses were retrospectively assessed as complete; optimal partial; and suboptimal response. Overall optimal response rate was the sum of complete and optimal partial response rates. RESULTS On the whole series, recurrence-free survival was significantly longer in patients who achieved an overall optimal response than in those who did not (p<0.0001), and in patients who received adjuvant chemotherapy compared to those who did not (p=0.0001). On multivariate analysis, consolidation therapy (p=0.0012) was the only independent prognostic variable for recurrence-free survival; whereas FIGO stage (p=0.0169) and consolidation therapy (p=0.0016) were independent prognostic variables for overall survival. CONCLUSION Optimal responders after chemo-surgical treatment for FIGO stage Ib2-IIb cervical cancer do not need any further treatment. Additional cycles of chemotherapy could be of benefit for patients with suboptimal response and intra-cervical residual disease. Both adjuvant chemotherapy and adjuvant radiation treatments do not seem to improve the clinical outcome of patients with extra-cervical residual disease compared to no further treatment.

Pathological response on surgical samples is an independent prognostic variable for patients with Stage Ib2–IIb cervical cancer treated with neoadjuvant chemotherapy and radical hysterectomy: An Italian multicenter retrospective study (CTF Study)

OBJECTIVES The purpose of this retrospective multicenter study was to correlate patterns of recurrences and clinical outcome of cervical cancer patients who underwent neoadjuvant chemotherapy [NACT] to surgery. METHODS This study was conducted on 333 patients with FIGO stage Ib2-IIb cervical cancer who underwent NACT to surgery with pelvic lymphadenectomy. The median follow-up was 66.5 months (range, 8-212 months). Overall optimal response rate was the sum of complete and optimal partial response rates. RESULTS An overall optimal response was obtained in 64 patients (19.2%). As for the 220 sub-optimal responders (66.1%), 127 patients had negative nodes and negative parametria and/or surgical margins, 75 patients had positive nodes with positive or negative parametria and/or surgical margins, and 18 patients had positive parametria and/or surgical margins with negative nodes. At the time of the present analysis, 79 (23.7%) of the 333 patients had a recurrence after a median time of 14.9 months (range, 4.5-123 months). Recurrent disease was pelvic in 50 (63.3%), extra-pelvic in 22 (27.9%), and both in 7 (8.8%). On multivariate analysis, pathological response to NACT was an independent prognostic variable for recurrence-free and overall survival. Patients who did not achieve an overall optimal response had a 2.757-fold higher risk of recurrence and a 5.413-fold higher risk of death than those who obtained an overall optimal response. CONCLUSIONS Results appear to suggest that the chemo-surgical approach is an effective therapeutic option for patients with stage Ib2-IIb cervical cancer and that pathological response to NACT is the strongest prognostic factor for the outcome.

The role of HE4 in ovarian cancer follow-up: a review.

Objective The aim of this review was to analyze the state of the art about HE4 and follow-up in patients treated for ovarian cancer. Methods A literature search was conducted in the MEDLINE database using the key words “HE4” and “ovarian cancer” and “recurrence” or “relapse” or “follow up.” Results Seven of 28 clinical studies were selected. Four studies were prospective, and all of them were based on a small number of patients (8–73 women). A failure of HE4 levels to normalize at completion of standard therapy may indicate a poor prognosis, thus suggesting the need of a closer follow-up. Moreover, HE4 showed better sensibility and specificity in the diagnosis of ovarian cancer recurrence with respect to CA-125, being also an earlier indicator of the relapse with a lead time of 5 to 8 months. HE4 showed a better performance in this setting if performed in association with other markers (CA-125, CA-72.4). HE4 seems to be an independent predictive factor for the surgical outcome at secondary cytoreductive surgery and to maintain its prognostic role even after the recurrence. Conclusions These preliminary data start to suggest a superiority of HE4 over CA-125 in the detection of ovarian cancer recurrence. Moreover, the prognostic role of HE4 could help clinicians to personalize the follow-up program, whereas its predictive role could be useful to plan the treatment of the relapse. The role of HE4 in ovarian cancer follow-up deserves to be further investigated in prospective randomized multicentric studies.

Variation in gynecological oncology follow-up practice: Attributable to cancer centers or to patient characteristics? A Piedmont Regional Oncology Network Study

AIMS AND BACKGROUND Although guidelines recommend minimalist follow-up, there is wide variability in gynecological oncology practice. The aims of this study were to describe between-center differences in the follow-up of endometrial, ovarian, and uterine cervical cancer; to identify the determinants of test prescription; to estimate the related costs; and to assess the weight of center habits and patient characteristics as sources of unexplained variability. METHODS AND STUDY DESIGN The medical records of patients treated between August 2004 and July 2005 for gynecological malignancies and followed up for the detection of recurrent disease were retrospectively collected from 29 centers of the Piedmont Oncology Network. Multivariate multilevel analyses were performed to study the determinants of test prescription and costs. RESULTS Analyses were performed on 351 patients (median follow-up: 578 days). The unexplained variability in computed tomography prescriptions (26%), ultrasound prescriptions (17%), and total cost of follow-up (15%) can be attributed to center habits, independenty of the clinical characteristics of the patients. CONCLUSIONS Much of the unexplained variability in the follow-up for gynecological malignancies is attributable to different habits of centers belonging to a cancer network. These results prompted us to design a multicenter randomized controlled trial to compare minimalist versus intensive follow-up programs in endometrial cancer.

A Search for Predictive Factors for Hypersensitivity Reactions to Paclitaxel and Platinum Salts in Chemotherapy for Gynecologic Pelvic Neoplasms

Aims: To investigate the frequency of and predictive factors for hypersensitivity reactions (HR) to taxanes and platinum salts in a cohort of patients treated for pelvic gynecologic malignancies. Methods: The medical records of all patients with gynecologic pelvic neoplasms treated with chemotherapy at the Department of Gynecologic Oncology, AO Mauriziano Umberto I of Turin, from September 2007 through August 2008, were retrospectively reviewed. Two multivariate models, regarding carboplatin and taxane chemotherapy, respectively, were performed to evaluate the potential predictive value of various clinical features. Results: The incidence of HR was 14% (22/157). Multivariate models showed that menopausal women had a significantly lower probability of HR (OR 0.12, CI 0.02–1.13, p = 0.06 for the carboplatin model and OR 0.05, CI 0.01–0.63, p = 0.02 for the taxane model) while a history of systemic hypersensitivity was associated with a higher but non-significant risk of HR (OR 2.64, CI 0.78–8.95, p = 0.11, for the carboplatin model and OR 3.42, CI 0.94–12.45, p = 0.06, for the taxane model). Conclusion: We confirmed a history of hypersensitivity as a risk factor for HR. Other larger cohorts should be analyzed: we need to find new predictive factors in order to select women who should be submitted to experimental prophylactic strategies.

Syringoid eccrine carcinoma: Case report of a rare tumor occasionally detected in the vulva

► Syringoid eccrine carcinoma (SEC) is a rare tumor. ► There are no published reports describing diagnosis of this tumor on the vulva. ► We report a case of a 58-year-old female with a SEC of left labia majora.

Diagnostic Accuracy And Cost-Effectiveness Of Different Strategies To Triage Adnexal Masses: A Prospective Study

Transvaginal sonography (TVS) and serum biomarkers are used widely in clinical practice to triage women with adnexal masses, but the effectiveness of current biomarkers is weak. The aim of this study was to determine the best method of diagnosing patients with adnexal masses, in terms of diagnostic accuracy and economic costs, among four triage strategies: (1) the International Ovarian Tumor Analysis groups simple rules (SR) for interpretation of TVS with subjective assessment (SA) by an experienced ultrasound operator when TVS results are inconclusive (referred to hereafter as SR ± SA), (2) SR ± SA and cancer antigen 125 (CA 125), (3) SR ± SA and human epididymis protein 4 (HE4) and (4) SR ± SA and the risk of malignancy algorithm (ROMA). Our main hypothesis was that the addition of the biomarkers to SR ± SA could improve triaging of these patients in terms of diagnostic accuracy (i.e. malignant vs benign). As secondary analyses, we estimated the cost effectiveness of the four strategies and the diagnostic accuracy of SR ± SA at the study hospitals.

Complications after the treatment of endometrial cancer: a prospective study using the French-Italian glossary.

Introduction The evaluation of treatment complications is crucial in modern oncology because they heavily influence the every day life of patients. Several authors confirmed the reproducibility of the French-Italian glossary to score the complications in patients with endometrial cancer after radiotherapy (RT), but the treatment of endometrial carcinoma is primarily surgical and chemotherapy is often used for high-risk disease. Objectives This study aimed to analyze the incidence of complications in our patients treated for endometrial cancer and to verify whether the glossary is a suitable instrument in the description of complications after surgery, RT, and chemotherapy. Methods The data of patients affected by endometrial cancer treated in the Gynecology and Obstetrics Academic Department, Azienda Ospedaliera Mauriziano Umberto I in Turin from 2000 to 2009 (with surgery alone or integrated treatments) were prospectively collected, and complications were described using the glossary. Every patient included in the analyses had a minimum of 18 months follow-up. Results Of the 271 patients, 68 (25%) experienced at least 1 complication with 87 overall complications. Most of the complications were mild (63%) and were found in the urinary (30%) or cutaneous systems (30%). Forty-four (50%) complications appeared within 1 year after treatment, but 9 (10%) complications appeared after 60 months of follow-up. Patients who were submitted to both surgery and RT showed a trend of higher rate of at least 1 complication (19/58 [32.7%]) if compared with surgery alone (36/135 [26.6%]), even if the difference was not statistically significant (P = 0.09). The incidence of complications in patients treated or not with lymphadenectomy was not statistically different (P = 0.088), whereas patients treated with laparotomy had a higher rate of cutaneous complications if compared with the laparoscopic approach (P = 0.018). The glossary included all observed complications. Conclusions One every 4 women treated for endometrial cancer develops a complication. Clinicians should check for complications especially after integrated treatments maintaining surveillance even in the long term. The glossary is a comprehensive instrument to describe the complications of endometrial cancer, regardless of the type of treatment delivered.

Is Ovarian Cancer Being Managed According to Clinical Guidelines? Evidence from a Population-Based Clinical Audit

Background In the northwestern Italian region of Piedmont, current statistics on hospitalizations show that surgical treatment for ovarian cancer (OC) is taking place in many small hospitals, as opposed to a more centralized approach. A population-based clinical audit was promoted to investigate whether OC is being managed according to clinical guidelines, identify determinants of lack of adherence to guidelines, and evaluate the association between adherence to guidelines and survival. Patients and Methods Residents diagnosed with OC in 2009 were identified in the regional hospital discharge records database. All hospitalizations within 2 years from diagnosis were reviewed. Patients were classified according to their initial pattern of care, defined as “with curative intent” (CIPC) if including debulking surgery aimed at maximal cytoreduction. Adherence to guidelines for surgery and chemotherapy and the effects of this adherence on OC survival were investigated with logistic regression and Cox models. Results The final study sample consisted of 344 patients with OC, 215 (62.5%) of whom received CIPC. Increasing age, comorbidities, and metastases were negatively associated with receiving CIPC. In the CIPC group, surgical treatment was adherent to guidelines in 35.2%, whereas chemotherapy was adherent in 87.8%. Surgical treatment that was adherent to guidelines [hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.45–1.15] and absence of residual tumor (HR, 0.55; 95% CI, 0.32–0.94) were associated with better survival in the CIPC group, and chemotherapy that was adherent to guidelines was associated with a significant reduction in the risk of death (HR, 0.49; 95% CI, 0.28–0.87). Conclusions Results support the need to reorganize the clinical pathway of patients with OC in the Piedmont Region and the need for better adherence to current guidelines.