IB Disease Research Articles

Y1-10: Adjuvant therapies: what we have learned in the last 5 years

Y1-10: Adjuvant therapies: what we have learned in the last 5 years

Salvage of isolated vaginal recurrences in women with surgical stage I endometrial cancer: a multiinstitutional experience

The objective of this study was to evaluate the treatment outcomes and risk factors of women with surgical stage I endometrial adenocarcinoma who were initially treated with surgery alone and subsequently developed isolated vaginal recurrences. Patients with surgical stage I endometrial adenocarcinoma diagnosed from 1975 to 2002 were identified from tumor registry databases at seven institutions. All patients were treated with surgery alone including a total hysterectomy, bilateral salpingo-oophorectomy, pelvic (+/− para-aortic) lymph node dissection, and peritoneal cytology and did not receive postoperative radiation therapy. Vaginal recurrences were documented histologically. Metastatic disease in the chest and abdomen was excluded by radiologic studies. Overall survival was calculated by the Kaplan–Meier method. Sixty-nine women with surgical stage I endometrial cancer with isolated vaginal recurrences were identified. Of the 69 patients, 10 (15%) were diagnosed with stage IA disease, 43 (62%) were diagnosed with stage IB disease, and 16 (23%) were diagnosed with stage IC disease. Patients diagnosed with grade 1 disease were 22 (32%), grade 2 disease were 26 (38%), and grade 3 disease were 21 (30%). Among women, 81% with isolated vaginal recurrences were salvaged with radiation therapy. The mean time to recurrence was 24 months, and the mean follow-up was 63 months. Among women, 18% died from subsequent recurrent disease. The 5-year overall survival was 75%. The majority of isolated vaginal recurrences in women with surgical stage I endometrial cancer can be successfully salvaged with radiation therapy, further questioning the role of adjuvant therapy for patients with uterine-confined endometrial cancer at the time of initial diagnosis

Mortality risk for stage I NSCLC with poor histologic grade, tumor size ≥4 cm, and non-upper lobe tumor location: An epidemiologic study of 19,702 patients in the California Cancer Registry from 1989 to 2003

7558 Background: Platinum-based adjuvant chemotherapy in randomized trials has failed to provide a survival benefit in stage I non-small-cell lung cancer (NSCLC). Using data from California Cancer Registry (CCR), we explored factors that have detrimental effect on survival in stage I NSCLC to identify a subset of patients at high risk for relapse and subsequent mortality. Methods: 19,702 stage I NSCLC cases in the CCR from 1989 to 2003 were identified and subgrouped into stage IA & IB disease. Patient demographic factors, tumor characteristics and treatment delivered were examined. Kaplan-Meier survival curves were calculated to estimate survival rates. Cox proportional hazards ratios were used to identify independent prognostic factors for survival. Results: Advanced age at diagnosis, male sex, low socioeconomic status (SES), non-surgical treatment & poorly-differentiated histologic grade (stage IA: hazard ratio [HR] = 1.14; 95% confidence interval [CI]: 1.08–1.19 & stage IB: HR = 1.11; 95% CI: 1.07–1.16) were factors identified with increased mortality risk on multivariate analysis. Non-upper lobe tumor location (RML/RLL/LLL) and tumor size ≥ 4 cm (vs < 4 cm; HR = 1.22; 95% CI: 1.15–1.30) were additional factors with increased mortality risk among stage IB patients. Conversely, bronchioloalveolar carcinoma (BAC)(vs adenocarcinoma: stage IA: HR = 0.81; 95% CI: 0.72–0.91 & stage IB: HR = 0.87, 95% CI: 0.77–0.98) & Asian ethnicity (vs Caucasian: stage IA: HR = 0.81, 95% CI: 0.70–0.94 & stage IB: HR = 0.80, 95% CI: 0.72–0.90) were associated with decreased mortality risk in stage I NSCLC. Lobectomy had the lowest HRs for death among all surgical techniques for both stage IA & IB NSCLC in the Cox proportional hazards model. Conclusions: Poorly-differentiated stage IA & IB NSCLC and stage IB NSCLC located in non-upper lobes or tumor size ≥ 4 cm carried an increased mortality risk on adjusted analysis. No significant financial relationships to disclose. [Table: see text]

Conservative surgical management of small‐volume stage IB1 cervical cancer

To determine outcomes of women with small-volume stage IB1 disease managed by conservative surgical treatment. A retrospective review. The Northern Gynaecological Oncology Center, Queen Elizabeth Hospital, Gateshead, UK. Women with stage IB1 cervical cancer who were managed by conservative surgery over a 6-year period between 1 January 2000 and 31 December 2005. Pelvic lymph node metastases, recurrence rates and outcome survival. A total of 17 women with conservatively managed stage IB1 cervical cancer were identified. Their ages were 25-67 years, median 37 years, 4 women were nulliparous. All women presented with an abnormal screening smear showing at least severe dyskaryosis. Estimated tumour volumes ranged from 16 to 640 mm3, median 72 mm3. Four women showed multifocal invasion. All four nulliparous women and one parous woman underwent fertility-sparing treatment, i.e. loop cone +/- laparoscopic pelvic node dissection. The other 12 women underwent laparoscopic assisted vaginal hysterectomy/total abdominal hysterectomy +/- pelvic lymph node dissection. There were no cases of residual disease in any of the definitive treatment specimens. There were no cases of metastatic spread to pelvic lymph nodes. To date, no women have developed recurrent disease, and all women are alive and well (median follow up, 29 months). The conservative surgical management of small-volume stage IB1 cases in this series showed an excellent outcome with no cases showing pelvic lymph node involvement and no cases developing recurrent disease. A more formal assessment of tumour volume with a more active approach to determining the third dimension will allow more women the option of conservative treatment, thereby minimising the adverse effects of radical surgery.

Accuracy of preoperative tumor grade and intraoperative gross examination of myometrial invasion in patients with endometrial cancer

Preoperative prediction of metastases to the regional lymph nodes in women with endometrioid endometrial cancer is a challenge. According to the Danish Gynaecological Cancer Society guidelines, a pelvic lymphadenectomy is warranted in all poorly differentiated tumors and all stage Ic disease. We have evaluated the accuracy of preoperative tumor grade and intraoperative gross examination of myometrial invasion, in predicting the need for a pelvic lymphadenectomy. Preoperative tumor grade and intraoperative gross examination of myometrial invasion were prospectively registered in 72 women with stage I endometrioid endometrial cancer, operated between 1 September 2004 and 18 April 2006. The pre- and intraoperative findings were compared with the final pathology report. The preoperative prediction of grade (well, moderate or poorly differentiated) was correct in 96% (69/72) of the patients. Gross examination of myometrial invasion correctly differentiated between stage Ia, Ib, and Ic disease in 89% (64/72) of the patients. The combination of preoperative tumor grade and intraoperative gross examination of myometrial invasion, led to wrong clinical decisions in 11% (8/72) of the patients. Three 'unnecessary' lymphadenectomies were performed, and 5 patients were primary operated upon without 'warranted' lymphadenectomy. Our data suggest that preoperative tumor grade and intraoperative gross examination of the uterus provide useful information for pre-and intraoperative planning of pelvic lymphadenectomy. However, wrong decisions were made in 11% of the patients, and more reliable evaluation methods are needed.

Pelvic Lymphadenectomy for Cervical Carcinoma: Laparotomy Extraperitoneal, Transperitoneal or Laparoscopic Approach? A Randomized Study

Although laparoscopic pelvic lymphadenectomy has several potential advantages for patients with early-stage cervical cancer, laparotomy still is viewed as the standard approach because laparoscopic surgery may not remove a sufficient number of diseased lymph nodes. This randomized study compared three surgical approaches in 168 consecutive patients proved to have invasive cervical carcinoma, all of whom were scheduled for radical hysterectomy and systematic pelvic lymphadenectomy. The participants, aged 70 or younger, had stage IB1 or stage IB2-IIB disease and had responded objectively to neoadjuvant chemotherapy. The methods evaluated were transperitoneal (TPL), extraperitoneal (EPL), and laparoscopic pelvic lymphadenectomy (LPL). Conventional radical hysterectomy was performed in all cases, and patients were evaluated 15 days and 1 and 2 months after surgery. The final study population numbered 161 patients. Both TPL and EPL removed an adequate number of pelvic lymph nodes in all instances, but LPL failed to do so in three instances. Overall feasibility, estimated on an intention-to-treat basis, exceeded 90% for all three procedures. Operating times for lymphadenectomy were longest for LPL, averaging 75 minutes, and least (averaging 54 minutes) for EPL. Average times in hospital ranged from 3.1 days for LPL to 5.6 days for TPL. Considering the entire operation, comparable proportions of patients in all three groups-approximating one in five-required blood transfusion. Lymphocysts were identified in 11 % of all patients. A few patients in each group had mild paresthesias that responded to physiatric therapy. The investigators conclude that, because laparoscopic radical hysterectomy is not yet a standardized procedure, the best approach to treating cervical cancer, once radical surgery is decided on, consists of EPL plus radical hysterectomy. Like LPL, EPL can shorten the time in hospital compared to TPL.

Salvage of isolated vaginal recurrences in women with surgical stage I endometrial cancer: a multiinstitutional experience

The objective of this study was to evaluate the treatment outcomes and risk factors of women with surgical stage I endometrial adenocarcinoma who were initially treated with surgery alone and subsequently developed isolated vaginal recurrences. Patients with surgical stage I endometrial adenocarcinoma diagnosed from 1975 to 2002 were identified from tumor registry databases at seven institutions. All patients were treated with surgery alone including a total hysterectomy, bilateral salpingo-oophorectomy, pelvic (+/- para-aortic) lymph node dissection, and peritoneal cytology and did not receive postoperative radiation therapy. Vaginal recurrences were documented histologically. Metastatic disease in the chest and abdomen was excluded by radiologic studies. Overall survival was calculated by the Kaplan-Meier method. Sixty-nine women with surgical stage I endometrial cancer with isolated vaginal recurrences were identified. Of the 69 patients, 10 (15%) were diagnosed with stage IA disease, 43 (62%) were diagnosed with stage IB disease, and 16 (23%) were diagnosed with stage IC disease. Patients diagnosed with grade 1 disease were 22 (32%), grade 2 disease were 26 (38%), and grade 3 disease were 21 (30%). Among women, 81% with isolated vaginal recurrences were salvaged with radiation therapy. The mean time to recurrence was 24 months, and the mean follow-up was 63 months. Among women, 18% died from subsequent recurrent disease. The 5-year overall survival was 75%. The majority of isolated vaginal recurrences in women with surgical stage I endometrial cancer can be successfully salvaged with radiation therapy, further questioning the role of adjuvant therapy for patients with uterine-confined endometrial cancer at the time of initial diagnosis.

Narrowband UVB and PUVA in the Treatment of Mycosis Fungoides: A Retrospective Study

Psoralen plus ultraviolet A (PUVA) is widely used as first-line therapy for treatment of mycosis fungoides. Narrowband ultraviolet B (NB-UVB) has also been shown to be effective for treatment of early mycosis fungoides. The aim of this retrospective study was to analyse the response to treatment and relapse-free interval for PUVA and NB-UVB therapies in mycosis fungoides. Forty patients were treated with PUVA or NB-UVB between 1980 and 2003. All patients had failed to respond to topical therapy or were unwilling to use it. PUVA therapy was used between 1980 and 1997. Thereafter, the choice between PUVA (twice a week) and NB-UVB therapy (three times a week) depended on stage and extent of the disease as well as on how far patients had to travel). Twelve patients (stage IA-IIB) were treated with NB-UVB and 28 patients (stage IA-IVA) with PUVA. No maintenance therapy was given. Six patients (50%) had a complete response, 4 (33%) had a partial response and 2 (16%) had a failed response to NB-UVB but had stable disease. PUVA led to a complete response in 18 (64%), a partial response in 6 (21%) and a failed response in 4 (14%) patients. The median relapse-free interval was 11.5 months in the NB-UVB treated group and 10 months in the PUVA group. The majority of the patients (79%) had stage IA and IB disease. Of these, 6 of 10 (60%) in the NB-UVB group and 13/21 (62%) in the PUVA group had a complete response to treatment. These results show that PUVA and NB-UVB are effective treatments for early mycosis fungoides.

A Multicenter Study on Oncologic Outcome of Laparoscopic Gastrectomy for Early Cancer in Japan

Laparoscopic surgery for gastric cancer is technically feasible, but it is not widely accepted because it has not been evaluated from the standpoint of oncologic outcome. We conducted a retrospective, multicenter study of a large series of patients in Japan to evaluate the short- and long-term outcomes of laparoscopic gastrectomy for early gastric cancer (EGC). The study group comprised 1294 patients who underwent laparoscopic gastrectomy during the period April 1994 through December 2003 in 16 participating surgical units (Japanese Laparoscopic Surgery Study Group). The short- and long-term outcomes of these patients were examined. Distal gastrectomy was performed in 1185 patients (91.5%), proximal gastrectomy in 54 (4.2%), and total gastrectomy in 55 (4.3%); all were performed laparoscopically. The morbidity and mortality rates associated with these operations were 14.8% and 0%, respectively. Histologically, 1212 patients (93.7%) had stage IA disease, 75 (5.8%) had stage IB disease, and 7 (0.5%) had stage II disease (the UICC staging). Cancer recurred in only 6 (0.6%) of 1294 patients treated curatively (median follow-up, 36 months; range, 13-113 months). The 5-year disease-free survival rate was 99.8% for stage IA disease, 98.7% for stage IB disease, and 85.7% for stage II disease. Although our findings may be considered preliminary, our data indicate that laparoscopic surgery for EGC yields good short- and long-term oncologic outcomes.

Brain metastasis from cervical carcinoma

The aim of this study was to describe the features of patients with brain metastasis from cervical cancer. Twelve patients with brain metastasis from cervical cancer were identified. Information regarding symptoms, treatment, and survival was analyzed. The incidence of brain metastasis in our population was 0.77%. Median patient age at initial diagnosis of cervical cancer was 43.5 years (range 29-57 years) compared with 44.5 years (range 31-58 years) at identification of brain metastasis. Six patients had FIGO stage IB disease; three had stage IIB disease; and one each had stage IIIA, IIIB, and IVB disease. The median interval from diagnosis of cervical cancer to identification of brain metastasis was 17.5 months (range 1.1-96.1 months). All but one patient presented with neurologic symptoms. Eight patients received whole-brain irradiation and steroids, three received steroids alone, and one underwent surgery, followed by irradiation. All the patients who received whole-brain irradiation experienced improvement in their symptoms. Median survival from diagnosis of brain metastasis to death was 2.3 months (range 0.3-7.9 months). Five patients who received chemotherapy after brain irradiation had a median survival of 4.4 months compared to 0.9 months for those who received no additional treatment after brain irradiation (P= .016). Most patients with brain metastasis from cervical cancer presented with neurologic sequelae. Brain irradiation improved these symptoms. Survival after diagnosis of brain metastasis was poor; however, patients who received chemotherapy after brain irradiation appeared to have improved survival.

The treatment of early stage cervical cancer: An assessment of pre-operative factors

To assess the pre-operative clinical factors of a group of early stage cervical cancer patients and correlate them to the risk for adjuvant radiotherapy using GOG 92 and 109 criteria. A retrospective chart review of cervical cancer patients treated at the Saint Louis University Division of Gynecologic Oncology between the years 1989 and 2004 was performed. The results were compared with chi-squared testing and multivariable regression analysis. A p-value of 0.05 was considered significant. One hundred and thirty-one cervical cancer patients underwent exploration for radical hysterectomy during the study time period. Five patients had stage IA1 disease, 6 patients had stage IA2 disease, 98 patients had stage IB1 disease, 20 patients had stage IB2 disease and one patient had stage IIA disease. No patient with stage IA1 or IA2 disease met criteria for adjuvant radiotherapy. The patients with stage IB1 tumors who were 45 years of age or younger and had tumors up to 2 cm in diameter had a low (14%) likelihood for treatment with adjuvant radiotherapy. The patients with stage IB1 tumors who were older than 45 years of age with tumors larger than 2 cm in diameter and the patients with stage IB2 tumors both had a high likelihood for adjuvant radiotherapy (77% and 90% respectively). In our study group, the stage of cervical cancer and a combination of tumor diameter and patient age was found to stratify early stage cervical cancer patients by likelihood for adjuvant radiotherapy.

Prognostic significance of [18F]fluorodeoxyglucose uptake on positron emission tomography in patients with pathologic stage I lung adenocarcinoma

[(18)F]Fluoro-2-deoxyglucose uptake on positron emission tomography (FDG-PET) has been frequently used for diagnosis and staging of lung cancer. The prognostic significance of FDG uptake on PET was evaluated in patients with pathologic Stage I lung adenocarcinoma (tumor stages were based on the TNM classification of the International Union Against Cancer). Disease-free survival of 98 patients with pathologic Stage I lung adenocarcinoma who were treated by curative resection was examined in relation to sex, age, histologic grade of differentiation, surgical procedure, tumor stage, and FDG uptake measured as the maximum standardized uptake value (SUV). Sixty-three patients were had Stage IA disease and 35 patients had Stage IB disease. Six patients each with Stage IA and Stage IB disease developed disease recurrence after a mean postsurgical follow-up period of 31 months. Ten (23%) of the 43 patients with SUV > or = 3.3 developed a recurrence compared with 2 (4%) of the 55 patients with SUV < 3.3 (P = .020). Ten (20%) of the 51 patients with moderately or poorly differentiated adenocarcinoma developed disease recurrence, compared with 2 (4%) of the 47 patients with well-differentiated adenocarcinoma (P = .056). Multivariate analysis demonstrated that histologic grade of differentiation was not correlated with the frequency of tumor recurrence (P = .286), whereas SUV was found to be marginally correlated (P = .079). FDG uptake appears to be predictive of disease-free survival in patients with Stage I lung adenocarcinoma. FDG uptake could yield important information for determining the likely value of postoperative adjuvant chemotherapy in such patients.

Oral Forodesine (Bcx-1777) Is Clinically Active in Refractory Cutaneous T-Cell Lymphoma: Results of a Phase I/II Study.

Background: Forodesine is a potent, rationally designed purine nucleoside phosphorylase (PNP) inhibitor that is orally bioavailable. IV forodesine has shown clinical activity in patients with cutaneous T-cell lymphoma (CTCL). The objective of this phase I/II study was to evaluate the safety, PK profile, and efficacy of oral forodesine in patients with refractory CTCL.Methods: An open-label dose-escalation study of fordesine, 40 to 320 mg/m2 qd for 4 weeks, was undertaken to evaluate the safety and PK profile of oral forodesine, followed by an investigation of the expansion of the optimal biologic dose (dose with maximum PNP inhibition and elevation of plasma deoxyguanosine levels) to assess efficacy. Previously treated, refractory CTCL patients with stage IB or greater disease were eligible for participation. The primary end point was objective response (OR) = complete response [CR] plus partial response [PR], as measured by the severity-weighted assessment tool (SWAT; see Figure) and physicians' global assessment (PGA)Results: Overall, 37 patients were treated, including 14 patients in the dose-escalation portion of the study. No dose-limiting toxicities were observed with target doses of ≤320 mg/m2; thus, a maximum tolerated dose was never defined. Based on PK/PD results, an 80 mg/m2 qd dose was identified as the optimal biologic dose, and this ongoing study was expanded to enroll a total of 28 patients (median age, 64 yr; range, 28–81 yr). The OR rate was 53.6% (15/28 patients; 2 [7.1%] with a CR and 13 [46.4%] with a PR). The proportion of patients with stage IIB or greater disease was 19/28 (67.9%). Response in this population was seen in 10 (52.6%) of the 19 patients (1 [5.3%] with a CR and 9 [47.4%] with a PR). The percent change in SWAT score from baseline as a function of time demonstrated a progressive decrease over a 24-week period. To-date, 12 (42.9%) of 28 patients have completed ≥4 months of treatment. Safety data were recorded for all 37 patients treated with forodesine. The most common adverse events classified as grade 2 or less, without regard to causality, were nausea (30%), dizziness (22%), pruritus (22%), fatigue (19%), headache (19%), peripheral edema (19%), and pyrexia (16%). The only adverse event classified as grade 3 or greater, without regard to causality, and occurring in at least two patients, was lymphopenia, which was observed in two patients (5%).Conclusions: Oral forodesine is effective in the treatment of refractory CTCL patients and has an encouraging safety profile. [Display omitted]

Ovarian Metastasis in Carcinoma of the Uterine Cervix

The goal of this study was to determine the frequency and histopathology of ovarian metastases in 3471 women having stage IB to IIB cervical cancer who underwent radical hysterectomy, pelvic lymph node dissection, and bilateral salpingo-oophorectomy in the years 1981 to 2000. Ovarian metastases were found in 52 women, 1.5% of the study population. Six patients with metastases had stage IB1 cervical cancer; 12, stage IB2 disease; 5, stage IIA disease; and 29, stage IIB cervical cancer. Incidence rates of ovarian metastasis progressed from 0.2% for those with stage IB disease to 2.2% for patients having stage IIb squamous cell carcinoma; and from 3.7% to 9.85%, respectively, for those with adenocarcinoma. Patients with adenocarcinoma were more likely than those with squamous cell cancer to have ovarian metastases (5.3% vs 0.8%). Outcomes were, in general, very poor and were not related to either the stage of cervical cancer or histologic type. No correlation was evident between ovarian metastasis and either lymph node involvement or parametrial invasion. The most common sites of distant recurrence were bone and lung. Five-year survival rates were 18% for patients having adenocarcinoma and 43.5% for those with squamous cell carcinoma. The investigators believe that the ovaries may be preserved in women having stage IB to IIA squamous cell carcinoma of the cervix but recommend that they be removed in those with adenocarcinoma.

Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial

Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC. 840 patients with stage IB-IIIA NSCLC from 101 centres in 14 countries were randomly assigned to observation (n=433) or to 30 mg/m(2) vinorelbine plus 100 mg/m(2) cisplatin (n=407). Postoperative radiotherapy was not mandatory and was undertaken according to every centre's policy. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN95053737. 367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. 301 (36%) patients had stage IB disease, 203 (24%) had stage II disease, and 325 (39%) had stage IIIA disease. Tolerance to chemotherapy mainly included neutropenia in 335 (92%) patients and febrile neutropenia in 34 (9%); seven (2%) toxic deaths were also recorded. Compliance was greater with cisplatin than with vinorelbine (median dose intensity 89% [range 17-108] vs 59% [17-100]). After a median follow-up of 76 months (range 43-116), median survival was 65.7 months (95% CI 47.9-88.5) in the chemotherapy group and 43.7 (35.7-52.3) months in the observation group. Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls (hazard ratio 0.80 [95% CI 0.66-0.96]; p=0.017). Overall survival at 5 years with chemotherapy improved by 8.6%, which was maintained at 7 years (8.4%). Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC, better defining indication of adjuvant chemotherapy.

Laparoscopically assisted radical vaginal hysterectomy (Coelio-Schauta): a comparison with open Wertheim/Meigs hysterectomy

The objective of this study was to compare the safety, efficacy, and short-term benefits of the Coelio-Schauta procedure with open Wertheim/Meigs radical abdominal hysterectomy. We retrospectively analyzed records of our first 35 consecutive patients undergoing laparoscopically assisted radical vaginal hysterectomy (LARVH) for early cervical cancer and 32 consecutive patients of open radical hysterectomy (ORH) performed between 1999 and 2005 in our institution. We analyzed patient age, bodyweight, previous abdominal surgery, operating time, blood loss, perioperative complications, postoperative bladder dysfunction, other postoperative complications, and histologic type. The FIGO stage, excision margins, node count and node status, follow-up, and recurrence rates were also taken into account. We excluded stage IA and stage II disease patients to reduce the impact of tumor size on the outcome of the surgery. This left 27 patients with stage IIB disease who had LARVH and 28 patients with stage IB disease who had ORH. These patients formed the study group. The cohorts were similar in age, bodyweight, previous abdominal surgery, histologic subtype, FIGO stage, resection margins, node count and node status, length of follow-up, and recurrence. There were statistically significant differences between LARVH and ORH for duration of surgery (mean 160 vs 132 min), intraoperative blood loss (479 vs 715 mL), hospital stay (mean 5 vs 9.3 days), postoperative complications (6 vs 20 patients), and duration of bladder catheterization (mean 4.4 vs 8.8 days). Four LARVH patients and no ORH patients had urinary tract injury that was repaired. None had long-term sequelae. Our data confirm that LARVH is a suitable alternative to ORH hysterectomy for small-volume stage IB1 cervical cancer with similar clinical efficacy and a superior postoperative recovery and postoperative morbidity profile. Urinary tract trauma is a clear risk in the early stages of the learning curve.

Fertility-sparing radical abdominal trachelectomy for cervical carcinoma: Technique and review of the literature

Objectives. Radical trachelectomy has emerged as a reasonable fertility-sparing operation for selected patients with stage I cervical cancer. The purpose of this report is to describe our technique of radical abdominal trachelectomy, a fertility-sparing operation in women with cervical cancer, and review the current literature on this procedure. Methods. A review of a prospectively maintained database of all fertility-sparing radical trachelectomy procedures performed at our institution. Results. Between 11/01 and 3/06, we performed a total of 42 fertility-preserving radical trachelectomies with pelvic lymphadenectomy for women with invasive cervical cancer. We had previously reported on 2 pediatric abdominal trachelectomies, which are excluded from this report. Five of the remaining 40 cases had undergone a radical abdominal trachelectomy, and 35 cases were performed laparoscopically with a radical vaginal approach. The characteristics of the 5 adult patients who underwent abdominal radical trachelectomy included stage IB1 disease in all cases, a mean age of 36 years (range, 33–39), and a mean estimated blood loss of 280 ml (range, 50–400); 1 patient with squamous cell carcinoma needed completion radical hysterectomy at the time of trachelectomy due to disease extending into the endometrium, and 1 patient needed postoperative chemoradiation due to a positive parametrial lymph node. The remaining 3 patients resumed normal menstruation postoperatively. All patients remain disease-free at the time of this report. The only remaining uterine blood supply in these patients are the utero-ovarian vessels. There were no postoperative complications, and transurethral Foley catheters were removed in all cases within 2 weeks. Conclusions. Radical abdominal trachelectomy with pelvic lymphadenectomy is a feasible operation for selected women with stage I cervical cancer who desire to preserve reproductive function. Menstruation and reproductive function may be preserved after bilateral uterine vessel ligation. The procedure expands the inclusion criteria of radical vaginal trachelectomy to patients with distorted cervicovaginal anatomy in which the vaginal approach may not be feasible.

The role of extensive lymphadenectomy in stage I ovarian cancer

5069 Background: To determine if extent of lymphadenectomy affects the survival of women with stage I ovarian cancer. Methods: Demographic and clinico-pathologic information were obtained from the Surveillance, Epidemiology and End Results Program from 1988–2001 and analyzed using Kaplan-Meier methods and Cox proportional hazards regression. Results: Of the 6,686 women diagnosed with stage I ovarian cancer, 4,092 (61.2%) had stage IA, 392 (5.9%) had stage IB, 1,840 (27.5%) had stage IC, and 362 (5.4%) had unspecified stage I disease. The median age was 53 (range: 1–99). 5,625 (84.1%) were White, 388 (5.8%) Black, 488 (7.3%) Asian, and 185 (2.8%) were Other. All patients underwent primary surgery; of which, 3,824 women had no nodes, 1,533 had &lt;10 nodes, and 1,329 had ≥10 nodes resected. Of the patients who underwent a lymphadenectomy, the median number of nodes resected was 9 (range: 1–84). The extent of lymphadenectomy (0, &lt;10, and ≥10 nodes) increased the survival of patients with stage IC disease from 72.8%, 86.7%, to 90.1% (p &lt; 0.0001), but not in those with stage IA (p = 0.07) or stage IB (p = 0.04) disease. In patients with non-clear cell epithelial carcinoma, the extent of lymphadenectomy was associated with improved 5-year disease-specific survivals of 85.6%, 93.3%, and 93.5%, respectively (p &lt; 0.0001). However, the benefit associated with an extensive lymphadenectomy was not evident in clear cell (p = 0.09), sarcoma (p = 0.33), germ cell (p = 0.55), or sex cord stromal tumors of the ovary (p = 0.99). Similarly, patients with grade 3 disease had an improved survival associated with the extent of lymph node resection, 74.4%, 87.5%, to 90.5% (p &lt; 0.0001), but not in those with grade 1 (p = 0.18) or grade 2 (p = 0.27) disease. In multivariate analysis, a more extensive lymphadenectomy remained significant as an independent prognostic factor for improved survival after adjusting for all other independent prognostic factors including age, surgery, histology, stage, and grade. Conclusions: Our findings suggest that the extent of lymphadenectomy was associated with an improvement in the survival of women with stage IC ovarian cancer. No significant financial relationships to disclose.

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Long‐term survival in a randomized study

Although surgical resection is considered the adequate treatment in early stages of nonsmall cell lung cancer, long-term survival is not satisfactory and recurrence rate is high. We previously showed that postoperative chemotherapy at stage IB reduces recurrences and prolongs overall survival. We extended size and observation period of the study sample and performed a separate analysis for minimally resected patients. The trial was designed as a randomized, 2-armed study with postoperative adjuvant chemotherapy versus surgery alone as control group. All patients had stage IB disease (pT2N0) assessed after a radical surgical procedure (defined as anatomical or minimal). Chemotherapy consisted of cisplatin (100 mg/m2 day 1) and etoposide (120 mg/m2 days 1-3) for 6 cycles. The primary endpoint was overall survival; secondary endpoint was disease-free survival (DFS). One hundred and forty patients entered the study: 70 were assigned to the adjuvant chemotherapy group and 70 to the control group. Groups were homogeneous for conventional risk factors. There was no clinically significant morbidity associated to chemotherapy. Patients were followed for a mean period of 40.31 +/- 30.86 months. A significant difference in overall (p = 0.02) and disease-free (p = 0.0001) survival was observed between patients undergoing adjuvant chemotherapy vs. control group. Adjuvant chemotherapy significantly improved both overall (p = 0.02) and DFS (p = 0.003) of anatomically resected patients, but only the DFS (p = 0.02) of minimally resected patients. Our results confirm that adjuvant chemotherapy may have a real impact on long-term survival in patients with stage IB nonsmall cell lung cancer being this effect especially evident for those anatomically resected.

Management of cervical cancer

Aims The aim of the article was to review the current approach to management of cervical cancer. Methods The relevant literature has served as a source for review of different options applied in the management of cervical cancer. Results Treatment of invasive cervical cancer is affected by the stage of the disease, which is based on clinical evaluation. Microinvasive carcinoma of the cervix has limited metastatic potential and therefore is most likely curable by non-radical treatment. There is no standard management of stage Ib–IIa cervical carcinoma. Both radical surgery and radical radiotherapy have proven to be equally effective, but differ in associated morbidity and complications. Most often, stage Ib1 cervical cancer is treated by radical hysterectomy with pelvic lymphadenectomy. Laparoscopically assisted radical vaginal hysterectomy has shown similar efficacy and recurrence rates. Radical vaginal trachelectomy with laparoscopic pelvic lymphadenectomy may be an option in small cervical cancer where preservation of fertility is desired. There is lot of conflicting published work regarding the treatment of bulky stage Ib–IIa cervical cancer. While some centers are performing primary surgery as for Ib1 disease followed by tailored postoperative radiation with or without chemotherapy, the others are in favor of primary chemo-radiation therapy. Neoadjuvant chemotherapy followed by radical surgery has emerged as a possible alternative, which may improve a survival in patients with stage Ib2 disease. Concomitant chemoradiation is becoming a new standard in treatment of advanced disease, because it has been clearly shown to improve disease-free, progression-free and overall survival. Management of recurrent disease depends on previous treatment, site and extent of recurrence, disease-free interval and patient's performance status. Conclusions Treatment decisions should be individualized and based on multiple factors including the stage of the disease, age, medical condition of the patient, tumor-related factors and treatment preferences, to yield the best cure with minimum complications.