今日の臨床サポート

子宮頸がん(初期):IA~IB2期

著者: 馬場長 岩手医科大学附属病院 産婦人科

監修: 青木大輔 慶應義塾大学医学部産婦人科学教室

著者校正済:2021/12/10
現在監修レビュー中
参考ガイドライン:
  1. 日本婦人科腫瘍学会編:子宮頸癌治療ガイドライン 2017年版
患者向け説明資料

概要・推奨   

  1. 子宮頸部前がん病変に対する適切な治療法は、子宮頸部円錐切除術が推奨される(推奨度2)
  1. 子宮頸がんIA1期に対する治療法は、骨盤リンパ節郭清を省略した単純子宮全摘術が推奨される(推奨度2)
  1. 子宮頸がんIB期の初回治療では、広汎子宮全摘術あるいは根治的放射線治療を行う。年齢、performance status (PS)、合併症、侵襲性などを総合して判断する(推奨度2)
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
馬場長 : 講演料(中外製薬,アストラゼネカ,科研製薬,オリンパス)[2022年]
監修:青木大輔 : 講演料(アストラゼネカ,武田薬品工業,中外製薬),研究費・助成金など(MSD,アストラゼネカ,中外製薬)[2022年]

改訂のポイント:
  1. 子宮頸癌治療ガイドライン 2017年版に基づき加筆修正を行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 子宮頸がんの死亡者は年間約3,000人、女性のがん死亡数に占める割合は約4%である。
  1. 年齢階級別罹患率は、40歳代、次いで30歳代に好発する。
  1. 子宮頸がんの組織型は80~90%を扁平上皮がんが占める。
  1. ⅠA期は組織学的にのみ診断できる浸潤がんのうち、間質浸潤が5mm以下のものを指す。
  1. ⅠB1期は病巣が2cm以下のもの、ⅠB2期は4cm以下のもの指す。
  1. リンパ節転移のあるものはⅢC期に分類されることとなった。
  1. HPV(human papilloma virus)の持続感染が病因として重要である。
  1. リスクファクターとしては、HPV持続感染、初回性交低年齢、喫煙、多産、経口避妊薬の使用、性交パートナーが多い、クラミジア感染などがある。
  1. 症状は、不正性器出血、接触出血、帯下などであるが、初期には無症状のことも多く、細胞診スクリーニングによる検診が重要である。
  1. 手術、化学療法、放射線療法、を適宜組み合わせることにより集学的加療を行う。
  1. わが国の進行子宮頸がんの治療成績を、日本婦人科腫瘍学会の指定修練施設と非指定施設で比較したところ、指定修練施設での治療予後が有意に優れていたことが示されている。
問診・診察のポイント  
  1. 年齢、喫煙歴、妊娠歴、出産歴、初経年齢、閉経年齢、性交の有無、職業歴、経口避妊薬の使用歴、HPVワクチン接種歴、性感染症(STD)の有無、婦人科検診歴および結果などの問診が重要である。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

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文献 

F Landoni, A Maneo, A Colombo, F Placa, R Milani, P Perego, G Favini, L Ferri, C Mangioni
Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer.
Lancet. 1997 Aug 23;350(9077):535-40. doi: 10.1016/S0140-6736(97)02250-2.
Abstract/Text BACKGROUND: Stage Ib and IIa cervical carcinoma can be cured by radical surgery or radiotherapy. These two procedures are equally effective, but differ in associated morbidity and type of complications. In this prospective randomised trial of radiotherapy versus surgery, our aim was to assess the 5-year survival and the rate and pattern of complications and recurrences associated with each treatment.
METHODS: Between September, 1986, and December, 1991, 469 women with newly diagnosed stage Ib and IIa cervical carcinoma were referred to our institute. 343 eligible patients were randomised: 172 to surgery and 171 to radical radiotherapy. Adjuvant radiotherapy was delivered after surgery for women with surgical stage pT2b or greater, less than 3 mm of safe cervical stroma, cut-through, or positive nodes. The primary outcome measures were 5-year survival and the rate of complications. The analysis of survival and recurrence was by intention to treat and analysis of complications was by treatment delivered.
FINDINGS: 170 patients in the surgery group and 167 in the radiotherapy group were included in the intention-to-treat analysis; scheduled treatment was delivered to 169 and 158 women, respectively, 62 of 114 women with cervical diameters of 4 cm or smaller and 46 of 55 with diameters larger than 4 cm received adjuvant therapy. After a median follow-up of 87 (range 57-120) months, 5-year overall and disease-free survival were identical in the surgery and radiotherapy groups (83% and 74%, respectively, for both groups), 86 women developed recurrent disease: 42 (25%) in the surgery group and 44 (26%) in the radiotherapy group. Significant factors for survival in univariate and multivariate analyses were: cervical diameter, positive lymphangiography, and adeno-carcinomatous histotype. 48 (28%) surgery-group patients had severe morbidity compared with 19 (12%) radiotherapy-group patients (p = 0.0004).
INTERPRETATION: There is no treatment of choice for early-stage cervical carcinoma in terms of overall or disease-free survival. The combination of surgery and radiotherapy has the worst morbidity, especially urological complications. The optimum therapy for each patient should take account of clinical factors such as menopausal status, age, medical illness, histological type, and cervical diameter to yield the best cure with minimum complications.

PMID 9284774
GlaxoSmithKline Vaccine HPV-007 Study Group, B Romanowski, P Colares de Borba, P S Naud, C M Roteli-Martins, N S De Carvalho, J C Teixeira, F Aoki, B Ramjattan, R M Shier, R Somani, S Barbier, M M Blatter, C Chambers, D Ferris, S A Gall, F A Guerra, D M Harper, J A Hedrick, D C Henry, A P Korn, R Kroll, A-B Moscicki, W D Rosenfeld, B J Sullivan, C S Thoming, S K Tyring, C M Wheeler, G Dubin, A Schuind, T Zahaf, Mary Greenacre, An Sgriobhadair
Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years.
Lancet. 2009 Dec 12;374(9706):1975-85. doi: 10.1016/S0140-6736(09)61567-1.
Abstract/Text BACKGROUND: Prophylactic human papillomavirus (HPV) vaccines have to provide sustained protection. We assessed efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6.4 years.
METHODS: Women aged 15-25 years, with normal cervical cytology, who were HPV-16/18 seronegative and oncogenic HPV DNA-negative (14 types) at screening participated in a double-blind, randomised, placebo-controlled initial study (n=1113; 560 vaccine group vs 553 placebo group) and follow-up study (n=776; 393 vs 383). 27 sites in three countries participated in the follow-up study. Cervical samples were tested every 6 months for HPV DNA. Management of abnormal cytologies was prespecified, and HPV-16/18 antibody titres were assessed. The primary objective was to assess long-term vaccine efficacy in the prevention of incident cervical infection with HPV 16 or HPV 18, or both. We report the analyses up to 6.4 years of this follow-up study and combined with the initial study. For the primary endpoint, the efficacy analysis was done in the according-to-protocol (ATP) cohort; the analysis of cervical intraepithelial neoplasia grade 2 and above (CIN2+) was done in the total vaccinated cohort (TVC). The study is registered with ClinicalTrials.gov, number NCT00120848.
FINDINGS: For the combined analysis of the initial and follow-up studies, the ATP efficacy cohort included 465 women in the vaccine group and 454 in the placebo group; the TVC included 560 women in the vaccine group and 553 in the placebo group. Vaccine efficacy against incident infection with HPV 16/18 was 95.3% (95% CI 87.4-98.7) and against 12-month persistent infection was 100% (81.8-100). Vaccine efficacy against CIN2+ was 100% (51.3-100) for lesions associated with HPV-16/18 and 71.9% (20.6-91.9) for lesions independent of HPV DNA. Antibody concentrations by ELISA remained 12-fold or more higher than after natural infection (both antigens). Safety outcomes were similar between groups: during the follow-up study, 30 (8%) participants reported a serious adverse event in the vaccine group versus 37 (10%) in the placebo group. None was judged related or possibly related to vaccination, and no deaths occurred.
INTERPRETATION: Our findings show excellent long-term efficacy, high and sustained immunogenicity, and favourable safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6.4 years.
FUNDING: GlaxoSmithKline Biologicals (Belgium).

PMID 19962185
W A Peters, P Y Liu, R J Barrett, R J Stock, B J Monk, J S Berek, L Souhami, P Grigsby, W Gordon, D S Alberts
Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix.
J Clin Oncol. 2000 Apr;18(8):1606-13.
Abstract/Text PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma.
PATIENTS AND METHODS: Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT.
RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group.
CONCLUSION: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.

PMID 10764420
Abstract/Text OBJECTIVE: The objective of this study was to evaluate the benefits and risk of adjuvant pelvic radiotherapy aimed at reducing recurrence in women with Stage IB cervical cancer treated by radical hysterectomy and pelvic lymphadenectomy.
METHODS: Two hundred seventy-seven eligible patients were entered with at least two of the following risk factors: >1/3 stromal invasion, capillary lymphatic space involvement, and large clinical tumor diameter. Of 277 patients, 137 were randomized to pelvic radiotherapy (RT) and 140 to no further treatment (NFT).
RESULTS: Twenty-one (15%) in the RT group and 39 (28%) in the NFT group had a cancer recurrence, 18 of whom were vaginal/pelvic in the RT and 27 in the NFT group. In the RT group, of 18 (13%) who died, 15 died of cancer. In the NFT group, of the 30 (21%) who died, 25 died from cancer. Life table analysis indicated a statistically significant (47%) reduction in risk of recurrence (relative risk = 0.53, P = 0.008, one-tail) among the RT group, with recurrence-free rates at 2 years of 88% versus 79% for the RT and NFT groups, respectively. Severe or life-threatening (Gynecologic Oncology Group grade 3 or 4) urologic adverse effects occurred in 4 (3.1%) in the RT group and 2 (1.4%) in the NFT group; 3 (2.3%) and 1 (0.7%) hematologic; 4 (3.1%) and 0 gastrointestinal (GI); and 1 (0.8%) and 0 neurologic, respectively. One patient's death was attributable to grade 4 GI adverse effects.
CONCLUSIONS: Adjuvant pelvic radiotherapy following radical surgery reduces the number of recurrences in women with Stage IB cervical cancer at the cost of 6% grade 3/4 adverse events versus 2.1% in the NFT group.

Copyright 1999 Academic Press.
PMID 10329031
D Bodurka-Bevers, M Morris, P J Eifel, C Levenback, M W Bevers, K R Lucas, J T Wharton
Posttherapy surveillance of women with cervical cancer: an outcomes analysis.
Gynecol Oncol. 2000 Aug;78(2):187-93. doi: 10.1006/gyno.2000.5860.
Abstract/Text OBJECTIVE: The aim of this study was to develop a surveillance program that optimizes clinical outcome following primary treatment of women with cervical cancer.
METHODS: The records of 1096 patients with FIGO stage IB cervical cancer treated from 1983 to 1993 were retrospectively reviewed. Recurrence was analyzed by site, presence or absence of symptoms, method of detection, and survival. Univariate and multivariate analyses using a Cox proportional hazards model were performed.
RESULTS: One hundred thirty-three patients (13%) developed recurrent disease. Of these, 114 were symptomatic and 19 were asymptomatic at the time of recurrence. Thirty-seven patients recurred in the central pelvis, 21 each in the lung or pelvic wall, 22 in nodes, and 35 in other sites. The median disease-free interval was 17 months for symptomatic patients and 16 months for asymptomatic patients. The median survival from initial diagnosis was 31 months for symptomatic and 83 months for asymptomatic patients (P = 0.001). The median survival from recurrence was 11 months for symptomatic and 42 months for asymptomatic patients (P < 0.001). Multivariate analysis revealed that symptom status at time of recurrence was a significant predictor of survival, even when known prognostic factors were considered (P < 0.001). All asymptomatic pelvic recurrences were diagnosed by pelvic exam; all asymptomatic pulmonary recurrences were detected by chest radiographs. Pap smears did not detect a single asymptomatic recurrence.
CONCLUSIONS: Posttherapy surveillance programs are directed toward asymptomatic patients in whom early detection of recurrence may impact survival. These data indicate that a subset of women may benefit from surveillance. A model for surveillance is proposed.

Copyright 2000 Academic Press.
PMID 10926801
J A Bolli, D L Doering, J R Bosscher, T G Day, C V Rao, K Owens, B Kelly, J Goldsmith
Squamous cell carcinoma antigen: clinical utility in squamous cell carcinoma of the uterine cervix.
Gynecol Oncol. 1994 Nov;55(2):169-73. doi: 10.1006/gyno.1994.1272.
Abstract/Text This study further defines the clinical utility of squamous cell carcinoma antigen (SCC-Ag) in initial squamous carcinoma of the cervix, response to treatment, and in the detection of recurrence. Serum specimens were drawn and analyzed from patients with squamous cell carcinoma. Charts were reviewed on 272 patients with 1053 samples evaluated. Treatment of patients prior to the availability of the assay and patients lost to follow-up resulted in lower total numbers of initial and recurrent values. Data were analyzed to detect trends during and after treatment. All values at or above the lowest detectable level of antigen were included; that is, 1.5 ng/ml and above. A SCC-Ag value > or = 2.0 ng/ml drawn at any time during the disease process has a 96.3% positive predictive value, while a value < 2.0 ng/ml is 97.2% specific for absence of disease. Fifty-three percent of 103 patients had elevated SCC-Ag levels prior to treatment, with the proportion increasing accordingly with advancing stage at diagnosis. In 70 patients with recurrence, 81% had elevated values. Squamous cell carcinoma antigen predicted recurrence an average of 6.9 months prior to detection of clinically evident disease. Patients with initially negative SCC-Ag levels may demonstrate elevated values with tumor recurrence. This marker accurately reflects the response to treatment in patients who have elevated levels prior to treatment. Squamous cell carcinoma antigen is a useful tumor marker in the management of patients with squamous cell carcinoma of the uterine cervix.

PMID 7959279
M D Esajas, J M Duk, H W de Bruijn, J G Aalders, P H Willemse, W Sluiter, B Pras, K ten Hoor, H Hollema, A G van der Zee
Clinical value of routine serum squamous cell carcinoma antigen in follow-up of patients with early-stage cervical cancer.
J Clin Oncol. 2001 Oct 1;19(19):3960-6.
Abstract/Text PURPOSE: To investigate the contribution to recurrence detection and survival of serum squamous cell carcinoma antigen (SCC-ag) analysis in the follow-up of early-stage cervical cancer patients.
PATIENTS AND METHODS: Follow-up data were evaluated in patients with early-stage squamous cell cervical cancer treated by radical hysterectomy and pelvic lymphadenectomy with or without radiotherapy. Routine serum SCC-ag determination was performed at each follow-up visit.
RESULTS: Recurrent disease occurred in 35 (16%) of 225 patients and was preceded or accompanied by serum SCC-ag elevation 26 times (sensitivity, 74%). In five (14%) of these 35 patients, elevated serum SCC-ag was the first measured clinical indicator. Desite salvage therapy, all five patients died of disease. In the other 31 patients (21 with serum SCC-ag elevation), either symptoms and/or positive signs led to recurrence detection. Median survival time after recurrence was worse (9 months; range, 2 to 112+) for patients with an elevated serum SCC-ag value at recurrence in comparison with patients with normal serum SCC-ag values (20 months; range, 4 to 96; P <.01). In 23 of the 190 patients without recurrences, serum SCC-ag values became falsely elevated. In 16 of these 23 patients, the repeat sample after 6 weeks showed a normal SCC-ag, and in seven patients benign (especially skin) disorders were found.
CONCLUSION: Serum SCC-ag analysis results in earlier recurrence detection in a small proportion (14%) of patients but did not contribute to better survival. As long as treatment possibilities for recurrent cervical cancer patients are not improved, serum SCC-ag analysis should not be carried out in routine follow-up.

PMID 11579117

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