Clear cell endometrial cancer: a CTF multicentre Italian study.

UNLABELLED: Endometrial clear cell carcinoma (CCC) is a rare entity and only accounts for 1-6% of all endometrial cancers. CCC is considered an aggressive subtype of endometrial cancer with worse prognosis compared with type I cancer and more frequent relapses at distant and extrapelvic sites. These characteristics require specific treatment modalities, but rarity of the disease does not allow to identify evidence based indications for therapies. Objective of the present study is to analyse a series of cases treated in a multicentre Italian setting. MATERIALS AND METHODS: Sixty-five endometrial CCC were treated in the period 1990-2010 in the participating institutions. Slides of the pathological specimens were reviewed by a single pathologist of each institution and debatable cases were collegially reviewed. Clinical records were collected by a common database. Demographic, surgical pathological, and follow-up data were registered. Results: All patients received primary surgery. Stage of disease according FIGO 2009 was as follow: l a: 16.9%, lb: 35.4%, 2: 9.2%, 3a: 9.2%, 3b: 3.1%, 3c: 16.9%, 4a: 3.1%, and 4b: 6.1%. Adjuvant post-operative treatment was adopted in 53.8% of cases. A relapse was detected in 29.2% of cases with a majority of extrapelvic sites (68.4%). Five-year survival rate was significantly related to stage of disease with an excellent prognosis for Stage Ia e lb disease with a complete staging. In these cases adjuvant treatment does not show significant improvement of survival. Relapsed cases show a response rate to treatment in 26% of cases (predominantly chemotherapy). CONCLUSION: CCC requires extensive surgical staging. Stage I disease completely staged does not require adjuvant therapy. More advanced stages require adjuvant chemotherapy.

Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib-II endometrial cancer: an Italian multicenter retrospective study (CTF study).

OBJECTIVES: The purpose of this retrospective study was to assess the clinical outcome of patients with high-risk, early-stage endometrioid endometrial cancer (stage Ib or II with myometrial invasion >50%, grade 2-3). METHODS: We assessed 192 patients who underwent hysterectomy, bilateral salpingo-oophorectomy and pelvic lymphadenectomy, had histologically negative pelvic nodes, and had negative CT findings for aortic node involvement. RESULTS: Tumor relapsed in 36 patients after a median time of 21.2 months. The recurrence was vaginal in 7 (19.4%), distant in 16 (44.4%), aortic in 8 (22.2%), and involved multiple sites in 5 (13.9%). There was a trend to a lower vaginal recurrence rate in the 143 patients who received adjuvant radiotherapy (+chemotherapy) compared with the 46 who did not (2.1% versus 8.7%). Distant or aortic recurrences were lower in the 37 patients who received adjuvant chemotherapy (+radiotherapy) than in the 152 who did not (2.7% versus 18.4%, p=0.02). Of the 29 patients who received sequential adjuvant chemotherapy and radiotherapy, none developed local recurrence and only one had distant recurrence. There was a trend for a better 5-year progression-free survival and overall survival for the patients who received chemotherapy (+radiotherapy) compared with those who did not (86.0% versus 71.3%, and 92.3% versus 75.6%, respectively). CONCLUSIONS: Our data appear to suggest that adjuvant chemotherapy reduces the risk of distant or aortic recurrences and that sequential adjuvant chemotherapy and radiotherapy achieve an excellent local and distant control of disease in these clinical settings.

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.

Cancer in pregnancy: maternal and fetal implications on decision-making.

BACKGROUND: Cancer complicates one out of 1,000 pregnancies. No standardized therapeutic interventions have been reported for these patients. METHODS: Fifteen patients with cancer during pregnancy were diagnosed between 6.5 and 36 weeks of gestational age between January 1991 and December 2007. RESULTS: Among the 15 cases one patient with early diagnosis (11 weeks) asked for interruption of pregnancy, two patients rejected chemotherapy in order to avoid fetal effects, seven patients underwent surgery during the first or second trimester, and two patients agreed to start the treatment only after delivery. Standard platinum-based chemotherapy (cisDDP) was postponed in six patients to the second trimester (administered after surgery in 2 cases). Chemotherapy was started between 18.3 and 29.6 weeks (median 22.3 weeks). One patient had pPROM (22.3 weeks) after chemotherapy with cisDDP. Ten patients were delivered by elective cesarean section and three by vaginal delivery. Mean gestational age at delivery was 33.5 weeks (range 32.1-40.0); mean weight at birth was 2,550 g (range 1,250-3,450). None of the newborns showed congenital malformations, and all had normal Apgar scores. Anemia occurred in two newborns. At a median follow-up of 56 months (range 2-198 months) all children were well and healthy. Eleven out of 15 mothers are alive and well, and one is alive with disease. An advanced neoplasm was diagnosed in three patients who died. CONCLUSION: When platinum-based chemotherapy is administered during the 2nd-3rd trimester, adverse effects in newborns are comparable to those in the general population. Deliberate treatment delay to achieve fetal viability or to improve fetal outcome may be reasonable for patients with early-stage cancer.

Non-hormonal treatment of vasomotor symptoms in gynecological cancer patients.

Gynaecological cancer patients generally suffer from an earlier and more severe menopausal syndrome than the general female population. Hormone replacement therapy is often contraindicated and there are non-hormonal treatments that are proven to be more effective than placebo in randomized controlled trials, e.g., some antidepressants, gabapentine and clonidine. The main limits to the use of these drugs in controlling hot flashes are the off-label use for this purpose, the very short follow-up and the fact that data come from studies performed on breast cancer, not on gynecological cancer patients. Patients believe that drugs derived from plants could be effective in relieving hot flashes and that they are harmless. Evidence is contrary to this belief and estrogen-sensitive cancer patients should be warned of the potential, though very weak, estrogenic effect of phytoestrogens and other "natural" drugs, and that their efficacy is close to that of a placebo.

Possible role of palliative surgery for bowel obstruction in advanced ovarian cancer patients.

OBJECTIVES: Bowel obstruction is a relatively common event (30-40%) in advanced or recurrent ovarian cancer patients. No definitive data are available on the optimal management of this serious complication and treatment is generally limited to adoption of palliative measures. These modalities include both surgical and medical procedures. The aim of this study was to define selection criteria for subjects who would benefit from palliative surgery. STUDY DESIGN: Out of 270 epithelial ovarian cancer patients treated in the period 1984-2005, 75 (28%) developed bowel obstruction related to progression/recurrence of the disease. Palliative treatment - both medical and surgical - was applied on an individual basis. A new score developed by these authors was retrospectivelly applied to this group of patients with the aim of defining a subgroup that could benefit from surgical treatment. RESULTS: Fifty cases (66.7%) were medically treated whereas 25 patients (33.3%) underwent surgery. Mean and median survival rates were 34 and 28 weeks in the surgical group versus 12 and four weeks in the medical group. Distribution according to score showed 53 cases (71%) in the low score group (< 14) and 22 (29%) in the high score group (> 14). A significantly better survival was observed in the low-score group (p < 0.0001) and in the surgically treated patients (p < 0.001). According to the risk score variables patients treated surgically for obstruction with low scores had a longer survival (p < 0.005) compared to medical treatment but this difference was not found in the high-risk group (p < 0.05). CONCLUSIONS: The prognosis of patients with bowel obstruction in relation to advanced ovarian cancer is best determined by comprehensive assessment of all prognostic parameters to define a subgroup of patients in a low-risk group that may benefit from surgical treatment.

Surveillance of endometrial pathologies, especially for endometrial cancer, of breast cancer patients under tamoxifen treatment.

Tamoxifen is the antihormonal treatment of choice for postmenopausal breast cancer patients with positive estrogen receptors. One of the most significant and deleterious side-effects of TAM treatment appears to be a proliferative effect on the endometrium, including endometrial cancer. Today no active screening for patients treated with tamoxifen other than routine annual gynecologic surveillance is recommended, however many investigators have recommended that those women should warrant closer gynecological surveillance for endometrial cancer during treatment, especially those with high-risk factors. This article evaluates the diagnostic flow chart for the surveillance of endometrial pathologies in tamoxifen-treated breast cancer patients, according to the literature and to the Committee Opinion of the Triveneto Directors of Gynecological and Obstetrical Departments (North-east Italy).

Could follow-up different modalities play a role in asymptomatic cervical cancer relapses diagnosis? An Italian multicenter retrospective analysis.

OBJECTIVE: The aim of this study was to evaluate how much clinical surveillance performed by follow-up scheduled appointments may correctly identify asymptomatic recurrences and describe the pattern of relapse detected by procedures. METHODS: The records of 327 consecutive women with recurrent cervical cancer treated from 1980 to 2005 were retrospectively collected in 8 Italian Institutions. Primary disease and recurrence data were picked up: diagnosis, type of treatment, FIGO stage, tumour grade, histology, clinical lesion size, number of localizations and site of relapse, presence of symptoms and primary method of detection, the type of treatment of recurrence and follow-up data, such as appointment date, clinical status and procedure performed. A multivariate analysis was carried out using the Cox proportional hazards regression model. Survival curves were calculated using the Kaplan-Meier technique. Survival differences were evaluated by the log-rank test. RESULTS: Sixty-seven out of 327 patients (20.5%) had a local recurrence on vaginal vault, 120 (36.7%) in central pelvis, 31 (9.5%) in pelvic wall, 16 cases (4.9%) in lymph nodes. Seventy-nine patients (24.2%) showed a distant relapse while 14 (4.3%) developed both a distant and local relapse. Among patients with distant relapses 39 (49.4%) had lung metastasis, 41 (51.9%) an hepatic recurrence, 4 (5.1%) a bone relapse. Among distant sites 32 out of 79 patients (40.5%) had single relapse and 46 (58.2%) had multiple localizations. The site of relapse influenced survival since patients with vaginal vault recurrences lived significantly longer than patients with recurrences in other sites. Ninety-seven (29.7%) patients were symptomatic and anticipated the scheduled visit, 66 (20.2%) reported their symptoms during the follow-up visit and 164 (50.1%) were asymptomatic and the diagnostic path was introduced by a planned visit or exam. Between asymptomatic patients the first procedure was clinical visit for 85 patients out of 164 patients (51.8%), imaging for 60 patients (36.6%), both clinical visit and imaging for 14 (8.5%) and cytology for 5 (3%, Pap smear test). The median OS of symptomatic patients was 37 months versus 109 months of asymptomatic patients (Log rank, p=0.00001). The median survival since recurrence was 9 months for symptomatic patients and median was not reached for asymptomatic patients (p<0.0001). The median disease-free interval was 24 months for asymptomatic patients vs. 36 months for symptomatic patients (p=0.03). CONCLUSIONS: Our study helps demonstrate the great need of prospective cost-effectiveness studies which are lacking at the present time.

Impact of an HPV diagnosis on the quality of life in young women.

OBJECTIVE: To evaluate the impact of the communication of an HPV diagnosis on the cognitive-behavioural aspect, emotional experiences, psychic-physical well-being, and psychosexual sphere in young women between the ages of 20 and 45. METHOD: During the period between February 2006 and March 2007, at the U.O. Department of Obstetrics and Gynecology of the ULSS 13 of Mirano (VE), we distributed three self-evaluating questionnaires (the CBA-20, the SAT-P, and the BISF-W) to 36 women who had been diagnosed with an HPV infection and 36 women who had never been diagnosed with HPV. RESULTS: 36% of the experimental group reacted to the diagnosis with fear and 29% reacted with anxiety, while in only 3% of the cases did the women react with anger. Significant differences emerged in two samples regarding state anxiety and obsessive and compulsive aspects, while there were no significant differences between the two groups regarding the subjective satisfaction with life quality and sexual function. A significant positive correlation was found between the sum of anxiety and fear expressed at the time of the diagnosis and the trait anxiety reported in the Cognitive Behavioural Assessment 2.0. CONCLUSIONS: The results indicate that the prevalent emotions felt at the time of the diagnosis are fear and anxiety. The persons who were diagnosed with an HPV infection resulted as having higher levels of trait anxiety, obsessions, compulsions, and above all, behaviours and worries related to hygiene and improbable infections.

Follow-up strategies in gynecological oncology: searching appropriateness.

Nowadays, the cost for oncology diseases is growing rapidly, in particular as a consequence of the introduction of new drugs and new diagnostic procedures, and becoming a considerable percentage of the global healthcare expense. On the other hand, a substantial amount of that cost is considered to be imputable to the follow-up procedures. The aim of our paper is to introduce the debate about follow-up policies adopted in gynecological oncology throughout a literature review just based on cost-effectiveness and cost-efficacy in order to explore if the data are consistent with evidences available in this field. Furthermore, it is discussed if common practice fits the needs of patients, gynecological oncologists, and health service. Despite the fact that in gynecological oncology we must consider different clinical situations concerning each specific neoplasm with their peculiar natural history, some general considerations could be drawn in order to set up future initiatives properly.

Ovarian metastases in early-stage cervical cancer (IA2-IIA): a multicenter retrospective study of 1965 patients (a Cooperative Task Force study).

This is a retrospective study of patients treated for early-stage cervical cancer to identify pathologic risk factors associated with ovarian metastases and, therefore, to establish when ovarian preservation can be performed without increasing the risk of relapse in order to improve the quality of life in premenopausal patients. Between 1982 and 2004, 1965 patients with FIGO stage IA2-IB-IIA cervical squamous cell carcinoma and nonsquamous histology types were surgically treated; 1695 (86%) patients underwent primary radical hysterectomy, bilateral salpingo-oophorectomy, and pelvic node dissection, the remaining 270 patients (14%) had their ovaries preserved. The clinical records were reviewed for all patients and clinical features at presentation, the histopathology and follow-up data were recorded. Overall, ovarian metastases were diagnosed in 16 of 1695 patients, for an incidence rate of 0.9%. Univariate analysis shows age (45 years: P = 0.0079), FIGO stage (IB1-IIA 4 cm: P = 0.0133), histology (squamous vs nonsquamous, P = 0.0014), noninvolved peripheral stromal thickness (<3 vs >3 mm: P = 0.0001), lymphvascular space involvement (present vs absent, P = 0.0007), lymph node status (positive vs negative, P = 0.00009) to be statistically associated with the presence of ovarian metastases. Multivariate analysis shows only age (P = 0.0119), FIGO stage (P = 0.011), histology (P = 0.001), and unaffected peripheral stromal thickness (<3 mm: P = 0.037) to be independent risk factors for ovarian metastases. Based on the present data and on the data available in the literature, ovarian preservation could be safely performed in young patients with early-stage squamous cell carcinoma (histology as the most significant risk factor), with macroscopically normal ovaries, and with preserved peripheral unaffected cervical stroma.

Surveillance procedures for patients treated for epithelial ovarian cancer: a review of the literature.

Epithelial ovarian cancer is the leading cause of death from gynecological cancer in the Western countries. Approximately 20%-30% of patients with early-stage disease and 50%-75% of those with advanced disease who obtain a complete response following first-line chemotherapy will ultimately develop recurrent disease, which more frequently involves the pelvis and abdomen. Few formal guidelines exist regarding the surveillance of these patients, and there is no agreement in the literature about the type and timing of examinations to perform. Moreover, the objective of follow-up is unclear as recurrent epithelial ovarian cancer continues to be a therapeutic dilemma and quite all the relapsed patients will eventually die of their disease. The follow-up of asymptomatic patients generally include complete clinical history, serum cancer antigen (CA)125 assay, physical examination, and often ultrasound examination, whereas additional radiologic imaging techniques are usually performed when symptoms or signs appear. (18)Fluoro-2-deoxy-glucose ((18)FDG)-positron emission tomography (PET) has a sensitivity of 90% and a specificity of 85% approximately for the detection of recurrent disease, and this examination appears to be particularly useful for the diagnosis of recurrence when CA125 levels are rising and conventional imaging is inconclusive or negative. Recently, technologic advances have led to novel combined (18)FDG-PET/computed tomography (CT) devices, which perform contemporaneous acquisition of both (18)FDG-PET and CT images. The role of (18)FDG-PET/CT for the detection of recurrent ovarian cancer is very promising, and this technique may be especially useful for the selection of patients with late recurrent disease who may benefit from secondary cytoreductive surgery.

Preoperative diagnosis of 221 consecutive ovarian masses: scoring system and expert evaluation.

OBJECTIVE: The aim of our work was to assess the diagnostic accuracy of a scoring system versus subjective assessment of the risk of malignancy of pelvic masses achieved by gynecologist/sonologists in the preoperative triage of a busy gynecology department. METHODS: One hundred and eighty-two consecutive patients who underwent surgical removal of ovarian neoplasms were examined. In 39 patients pelvic masses were bilateral. The total number of neoplasms analyzed in this series was 221. Lesions were examined and scored according to the sonographic characteristics. Gynecologist/sonologists also recorded a subjective evaluation of the adnexal masses defining them as "probably benign", and "suspicious/probably malignant". Preoperative ultrasound risk assessment was compared to the final pathologic report and diagnostic accuracy was calculated. CA125 was obtained in all patients and its independent and combined accuracy was calculated. RESULTS: The sensitivity of the scoring system and subjective evaluation was 86% and 95% respectively, specificity was 79% and 91% with a positive predictive value of 41% and 53%. The frequency of positive diagnoses for CA125 was 44% due to the high prevalence of endometrosis in this series (48%). In premenopausal patients (75%) the specificity was 93% and 89% for scoring and subjective evaluation, respectively. The combined use of morphological scoring and CA125 achieved higher specificity and positive predictive values both for the whole series and in premenopausal patients. CONCLUSIONS: These results confirmed that the experience of gynecological surgeons with ultrasound skills, outperforms the morphological indexing assessment of ovarian masses. Nonetheless an easy sonographic descriptive scoring system is not significantly lower in accuracy than the expertise achieved by gynecologists with sonographic skills.

Efficacy of an acidic vaginal gel on vaginal pH and interleukin-6 levels in low-risk pregnant women: a double-blind, randomized placebo-controlled trial.

BACKGROUND: Increased interleukin-6 (IL-6) levels and a vaginal pH of > 4.7 are associated with obstetric complications such as preterm delivery and low birth weight. Topical treatments, able to maintain a physiological vaginal pH, could help in the prevention of vaginal infections. STUDY AIM: In a randomized, double-blind, placebo-controlled trial, we evaluated the effects of an acidic buffering vaginal gel (Miphil) on vaginal pH and IL-6 levels in pregnant women. PATIENTS AND METHODS: Seventy low-risk women pregnant with a singleton (second trimester) were enrolled in the trial. Thirty-five were randomized to the acidic gel, 2.5 g every 3 days for 12 weeks, and 35 to the corresponding placebo. Vaginal pH and vaginal IL-6 level were measured at baseline and after 12 weeks. Women were then followed until delivery. The main outcome measures were vaginal pH, vaginal pH normalization (pH < 4.5) and vaginal IL-6 levels. RESULTS: Vaginal pH at baseline was 4.6 +/- 0.4 and 4.4 +/- 0.3 in the acidic gel and the placebo group, respectively. At baseline, a total of 40% (14/35) and 22% (8/35) of women in each group, respectively, had a vaginal pH of > or = 4.7. At week 12, the vaginal pH was 4.3 +/- 0.3 in the acidic gel group and 4.3 +/- 0.3 in the placebo group (NS). The acidic gel normalized the vaginal pH in ten out of 14 women (p = 0.04) in comparison with only one out of eight women in the placebo group (NS). The acidic gel induced a significant (p < 0.02) reduction of vaginal IL-6 from 12.0 +/- 7 to 8.9 +/- 5 pg/l (-36%). In the placebo group, IL-6 increased from 9.0 +/- 5 to 13.5 +/- 6.8 pg/l (+50%) (p = 0.05). Birth weight was 2978 +/- 700 g in the placebo group and 3241 +/- 477 g in the acidic gel group (p = 0.06). CONCLUSIONS: The use of the acidic gel in low-risk pregnant women is able to maintain a physiological vaginal ecosystem and prevents the increases of vaginal pH and vaginal IL-6. Prospective and controlled trials are warranted to evaluate whether this acidic gel can reduce obstetric complications linked to vaginal inflammation during pregnancy.

An analysis of different approaches to ovarian cysts in Italy.

UNLABELLED: The management of pelvic masses represent a rising problem due to the need to obtain an early diagnosis and treatment of ovarian cancers. MATERIALS AND METHODS: In order to evaluate the clinical and surgical approach to ovarian cysts in Italy, we sent a multiple choice questionnaire to 214 members of the Italian Society of Gynecologic Oncology (SIOG) and to 230 members of the Italian Society of Gynecologic Endoscopy (SEGi). Ninety-six resulted evaluable. RESULTS: Transabdominal and transvaginal ultrasound associated with CA125 determination represent the basis for the diagnosis, even if there is no univocal agreement on the ultrasound aspects that may define an ovarian cyst as doubtful. If an ovarian cyst, classified as suspicious, has been diagnosed in a postmenopausal woman, a wide range of therapeutic options have been reported: laparotomic hysterectomy and bilateral salpingo-oophorectomy represent the treatment of choice for 49% of SIOG members, whereas laparoscopic bilateral (45%) or monolateral (39%) salpingo-oophorectomy represents the standard for SEGi members. Ultrasound criteria to distinguish among benign or probably malignant or doubtful ovarian cysts, the treatment of an ovarian cyst during pregnancy, and the management of an unexpected intraoperative diagnosis of borderline ovarian neoplasia are discussed on the basis of answers received by SIOG and SEGi members.

The clinical outcome of patients with stage Ia1 and Ia2 squamous cell carcinoma of the uterine cervix: a Cooperation Task Force (CTF) study.

PURPOSE OF INVESTIGATION: The objective of this retrospective multicenter study was to assess the clinical outcome of patients with microinvasive squamous cell carcinoma of the uterine cervix. METHODS: The hospital records of 166 patients with microinvasive squamous cell carcinoma of the uterine cervix were reviewed. All cases were retrospectively staged according the 1994 International Federation of Gynecology and Obstetrics (FIGO) nomenclature. One hundred and forty-three cases were in Stage Ia1 and 23 in Stage Ia2 disease. Surgery consisted of conization alone in 30 (18.1%) patients, total hysterectomy in 82 (49.4%), and radical hysterectomy in 54 (32.5%). All patients in whom conization was the definite treatment had Stage Ia1 disease and had cone margins negative for intraepithelial or invasive lesions. RESULTS: None of the 67 patients submitted to pelvic lymphadenectomy had histologically proven metastatic lymph nodes. Of the 166 patients, eight (4.8%) had an intraepithelial recurrence and four (2.4%) had an invasive recurrence. With regard to FIGO substage, disease recurred in nine (6.3%) out of 143 patients with Stage Ia1 and three (13.0%) out of 23 with Stage Ia2 cervical cancer. With regard to type of surgery, disease recurred in three (10.0%) out of the patients treated with conization alone, four (4.9%) out those who underwent total hysterectomy, and five (9.3%) out of those who underwent radical hysterectomy. It is worth noting that none of the 30 patients treated with conization alone had recurrent invasive cancer after a median follow-up of 45 months. However three (10%) of these patients developed a cervical intraepithelial neoplasia (CIN) III after 16, 33, and 94 months, respectively, from conization. CONCLUSIONS: Conization can represent the definite treatment for patients with Stage Ia1 squamous cell cervical cancer, if cone margins and apex are disease-free. For patients with Stage Ia2 cervical cancer extrafascial hysterectomy with pelvic lymphadenectomy might be an adequate standard therapy, although the need for lymph node dissection is questionable.

The role of the French-Italian glossary of complications in the outcome evaluation of cervical cancer treatment: an Italian multicentric study.

UNLABELLED: The optimal treatment for cervical cancer is still a controversial matter: in the last two decades a lot of different modalities combining surgery, radiotherapy (RT) and chemotherapy (CHT) have been suggested and analysed in clinical trials. Nevertheless, analysis of treatment in cancer patients should be directed not only to survival, but also to the cost of complications and quality of life. In June 1988, a French-Italian co-operative group set up a glossary in which the complications of the treatment of cervical cancer are described and ranked. Nowadays, this is the only international system based upon an accurate description of symptoms and signs of complications following multidisciplinary treatment. The glossary was based on our previous experience in treating patients by surgery alone, RT or their combinations. Recently multimodality treatment includes also CHT. The aim of the present study was to verify whether the glossary is still a useful clinical instrument in outcome evaluation of cervical cancer treatment. MATERIALS AND METHODS: The analysis has been done on a retrospective consecutive series of 579 patients affected by cervical cancer, treated in five Italian institutions. A minimum of 12 months follow up was required. All medical records of the patients enrolled, were examined by two independent reviewers in order to classify the complications according to the glossary. RESULTS: Out of 579 patients 319 (55.1%) were free of complications and 260 (44.9%) experienced at least one complication. We found 436 complications. The distribution by Grade was: G1 58.9%, G2 27.5%, G3 13.5%. We had no fatal complication (G4). The glossary included all observed complications, except for pulmonary fibrosis. CONCLUSION: The glossary is still a useful instrument in evaluating the outcome of cervical cancer treatment, whatever the therapy, and should be considered in quality of life assessment.

Factors influencing survival in endometrial cancer relapsing patients: a Cooperation Task Force (CTF) study.

The purpose of this study was to identify patterns of relapse and to determine the outcome of salvage treatment and the factors influencing survival of endometrial cancer relapsing patients. One thousand six hundred and six endometrial cancer (stages I to IV) patients treated at five Italian institutions were retrospectively reviewed. Of these, 209 (13%) subjects had recurred; the site of relapse was vagina in 35 cases (16.7%), pelvis in 67 (32.1%), and distant locations in 107 (51.2%). Most of the patients relapsed within 24 months: 45% (94) recurred within 1 year, 20.6% (43) between 1 and 2 years. Adjuvant radiotherapy (RT) seemed to reduce the percentage of pelvic recurrence in high risk early stages (IB-IIA) subjects and a higher proportion of patients failed at a distant site when postoperative external-beam pelvic RT was given. However survival curves were not statistically different in the two groups for stage IB endometrial cancer patients. Five and 10-year survival rates of patients with recurrent disease was 26% and 22%, respectively. Relapse of endometrial cancer is often early and at distant sites. Survival rate was related to site of relapse, disease-free interval, and postoperative treatment as independent prognostic variables. The site of relapse is the most important predictor of survival of patients with recurrent disease.