Long-Term Follow-up of the First Randomized Trial Using Neoadjuvant Chemotherapy in Stage Ib Squamous Carcinoma of the Cervix: The Final Results

Je, Sardi; Giaroli, Adolfo; Sananes, Carlos; Ferreira, M.; Soderini, Alejandro; Bermúdez, Adriana; Snaidas, L.; Vighi, Susana; N, Gomez Rueda; G, di Paola

doi:10.1006/gyno.1997.4812

Cited by 231 publications

(181 citation statements)

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“…(I) Sardi et al (1997) (12) A RCT was conducted for stage IB squamous cell carcinoma in NCS + RT and surgery + RT groups. The NAC regimen was cisplatin (CDDP) + vincristine (VCR) + bleomycin (BLM).…”

Section: Clinical Research On the Efficacy Of Nacmentioning

confidence: 99%

“…In Europe, Japan and Latin countries, NAC followed by surgery (NCS) has emerged as a valid alternative and several pilot studies have shown a large benefit over RT alone in terms of overall survival (OS) and disease-free survival (DFS) (11). The best evaluation of the addition of chemotherapy to surgery is through a direct comparison with surgery alone, But when compared with primary surgery, the efficacy of NCS has not been determined in previous randomized controlled trials (RCTs) (5,(12)(13)(14) or observational studies (15)(16)(17). Recent reviews of NCS for cervical cancer have shown no significant benefit in OS over surgery alone (18,19).…”

Section: Introductionmentioning

confidence: 99%

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Neoadjuvant chemotherapy for locally advanced cervical cancer

2003

European Journal of Cancer

271

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Neoadjuvant chemotherapy followed by surgery (NCS) has not been fully evaluated clinically. Currently, the main regimen of neoadjuvant chemotherapy (NAC) used in NCS includes cisplatin. The antitumor effects of NAC reduce lymph node metastasis and the tumor diameter in patients prior to surgery, and this can reduce the number of high risk patients who require postoperative radiation therapy. Many randomized controlled trials (RCTs) have examined the long-term prognosis of NCS compared to primary surgery, but the utility of NCS remains uncertain. The advent of concurrent chemoradiotherapy (CCRT) has markedly improved the outcome of radiotherapy (RT), and CCRT is now used as a standard method in many cases of advanced bulky cervical cancer. NCS gives a better treatment outcome than radiation therapy alone, but it is important to verify that NCS gives a similar or better outcome compared to CCRT.

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Section: Clinical Research On the Efficacy Of Nacmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Neoadjuvant chemotherapy for locally advanced cervical cancer

2003

European Journal of Cancer

271

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“…In addition, it may serve to control micrometastatic disease and so improve survival. Previous studies have relied on clinical evaluation by pelvic examination with or without ultrasonography to assess the response (Eddy et al, 1995;Lai et al, 1997;Sardi et al, 1997;Benedetti-Panici et al, 1998;Hwang et al, 2001). Reductions in tumour volume of up to 100% with as many as 15 -20% having complete clinical response after three cycles of chemotherapy (Lai et al, 1997;Benedetti-Panici et al, 1998) have been reported, but on comparison with subsequent histopathology these assessments have been shown to be inaccurate (Eddy et al, 1995).…”

Section: Discussionmentioning

confidence: 99%

“…Neoadjuvant chemotherapy has been advocated prior to radical hysterectomy in locally advanced cervical carcinoma because it may serve to control micrometastatic disease and so improve survival (Sardi et al, 1997;Benedetti-Panici et al, 1998;Hwang et al, 2001). In addition, it offers the potential to reduce tumour volume and thus improve surgical resectability (Eddy et al, 1995).…”

mentioning

confidence: 99%

Use of neoadjuvant chemotherapy prior to radical hysterectomy in cervical cancer: monitoring tumour shrinkage and molecular profile on magnetic resonance and assessment of 3-year outcome

et al. 2004

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The objective of this study is to assess tumour response to neoadjuvant chemotherapy prior to radical hysterectomy in cervical cancer using magnetic resonance (MR) to monitor tumour volume and changes in molecular profile and to compare the survival to that of a control group. Eligibility included Stage Ib -IIb previously untreated cervical tumours 410 cm 3 . Neoadjuvant chemotherapy in 22 patients (methotrexate 300 mg m À2 (with folinic acid rescue), bleomycin 30 mg m À2 , cisplatin 60 mg m À2 ) was repeated twice weekly for three courses and followed by radical hysterectomy. Post-operative radiotherapy was given in 14 cases. A total of 23 patients treated either with radical surgery or chemoradiotherapy over the same time period comprised the nonrandomised control group. MR scans before and after neoadjuvant chemotherapy and in the control group documented tumour volume on imaging and metabolites on in vivo spectroscopy. Changes were compared using a paired t-test. Survival was calculated using the Kaplan -Meier method. There were no significant differences between the neoadjuvant chemotherapy and control groups in age (mean, s.d. 43.3710, 44.778.5 years, respectively, P ¼ 0.63) or tumour volume (medians, quartiles 35.8, 17.8, 57.7 cm 3 vs 23.0, 15.0, 37.0 cm 3 , respectively, P ¼ 0.068). The reduction in tumour volume post-chemotherapy (median, quartiles 7.5, 3.0, 19.0 cm 3 ) was significant (P ¼ 0.002). The reduction in -CH 2 triglyceride approached significance (P ¼ 0.05), but other metabolites were unchanged. The 3-year survival in the chemotherapy group (49.1%) was not significantly different from the control group (46%, P ¼ 0.94). There is a significant reduction in tumour volume and -CH 2 triglyceride levels after neoadjuvant chemotherapy, but there is no survival advantage.

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“…In certain trials, a small number of women had radical surgery as an alternative to radical radiotherapy [28]; [29], and in another most women had radical surgery followed by adjuvant radiotherapy [30]. Most of the 2074 women in the trials had FIGO stage II-III tumours, but some trials included women with stage IB disease.…”

Section: Neoadjuvant Chemotherapy Prior To Radical Radiotherapy Versumentioning

confidence: 99%

Concomitant and Neoadjuvant Chemotherapy for Cervical Cancer

Tierney¹,

Vale²,

Symonds³

2008

Clinical Oncology

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In the past, women with early stage cervical cancer have been treated with radical radiotherapy or radical surgery, and women with locally advanced disease with radical radiotherapy, each offering a good chance of cure. Numerous trials have investigated whether giving cytotoxic chemotherapy alongside radiotherapy or prior to local treatment could augment the established benefits of these therapies, and are reviewed here. There is a strong basis for the use of platinum-based chemoradiotherapy, the current standard of care, but little convincing evidence as to the therapeutic benefits of using concomitant hydroxyurea. Chemoradiotherapy based on other non-platinum agents may offer alternatives. The effect of chemoradiotherapy appears to vary according to the stage of disease, but all types of women benefit. Neoadjuvant chemotherapy prior to radiotherapy could jeopardise survival and should be avoided unless perhaps a 'quick', dose intense regimen is used. Neoadjuvant chemotherapy before surgery may be beneficial, but the approach will remain controversial until it is tested against platinum-based chemoradiotherapy. Future studies many include combinations of other cytotoxics such as topotecan with cisplatin-based concomitant chemoradiotherapy or the addition of agents targeted against specific receptors such as EGFR.

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Long-Term Follow-up of the First Randomized Trial Using Neoadjuvant Chemotherapy in Stage Ib Squamous Carcinoma of the Cervix: The Final Results

Cited by 231 publications

References 0 publications

Neoadjuvant chemotherapy for locally advanced cervical cancer

Neoadjuvant chemotherapy for locally advanced cervical cancer

Use of neoadjuvant chemotherapy prior to radical hysterectomy in cervical cancer: monitoring tumour shrinkage and molecular profile on magnetic resonance and assessment of 3-year outcome

Concomitant and Neoadjuvant Chemotherapy for Cervical Cancer

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