1. A Template for Clinical Drawings in Cancer of the Cervix Carey B. Shenfield MD Johannes C.A. Dimopolous MD Heloisa De Andrade Carvalho MD PhD Elena F. Fidarova MD Richard Pötter MD

2. Clinical Drawings Clinical drawings have traditionally been used to depict the extent of disease based on clinical examination. Tumour that is visible or palpable is drawn manually, usually on paper templates. With the advent of image-guided brachytherapy in cervical cancer, an argument can be made to also incorporate disease findings from imaging examinations into these “clinical drawings”. We aim to develop standarized methods for the creation of these clinical drawings, that would hopefully, eventually, lead to some level of standardization of clinical drawings across different physicians, across different centres, across time, and ultimately, across multiple tumour sites as well.

3. Clinical Drawings “At Diagnosis” or “At Brachytherapy” should be marked on each drawing. Treatment received to date, including any external beam radiotherapy (EBRT) delivered to date, should be noted. Four different views or planes are illustrated: Specular, Axial, Coronal, and Sagittal. Dotted lines of the vagina represent a virtual division in thirds. Dotted lines in the parametria represent a border between the proximal and distal half of the parametria. A pink line in the coronal view represents uterine artery.

4. Tumour dimensions: height (h), width (w), and thickness (t) should be documented. Height, defined on the sagittal view, is measured along the long axis of the uterus. Thickness, defined on the sagittal view, is measured perpendicular to the height. Width, measured on the axial view, represents the greatest lateral diameter. Vaginal extension of tumour is specified separately. The date of the evaluation should be recorded. The drawing should be signed. Clinical Drawings

5. There are three basic options for the drawing of uniform and reproducible universal clinical drawings. A first option utilizes coloured marker pens and a colour legend. Four different, specific colours are used. In addition, tumour can be identified as exophytic in nature by changing the border as outlined in the legend. There are certain advantages to coloured marker approach, such as straightforward and quick implementation, and immediately recognizable distinctions of different anatomical areas of involvement. However, the incorporation of up to four specifically coloured markers into routine clinical practice in clinics and operating rooms may be a challenge to do consistently. Ensuring the consistent availability of the markers in multiple work environments, with multiple caregivers, may not be practical. Clinical Drawings Manual Colour Drawing

6. A second option uses a legend that requires only a single pen to convey the same amount of information. Different anatomical areas of involvement are demonstrated using simple line patterns, with a specific pattern for each anatomical site according to the legend. Again, any exophytic tumour can be delineated with a special border. Unlike the colour approach, consistent availability of a pen at any location or with any caregiver should not be an issue. A drawback is that the drawings may appear less readily discernible. However, after a brief learning curve, practioners should be able to draw and read such drawings with ease. This approach seems the most practical and reliable, and could be adopted widely. Clinical Drawings Manual Line Drawing

7. Finally, a third option involves a computer-based method to create the clinical drawings. This method involves electronic versions of the colour or background lines templates, with electronically modifiable tumour cartoons. The cartoons can be modified for the individual patient by way of a Powerpoint © type of application, using relatively simple tools (Figures 3, 4). Clinical drawings can be stored and transmitted electronically. Drawings for physical medical chart record-keeping would have to be printed. Clinical Drawings Electronic Drawing

8. Advantages of an electronic approach include the consistency and clarity of the drawings produced. In addition, the electronic format facilitates the storage, access, and distribution of the drawings. Electronic templates could be made available on the internet for clinical use. However, logistical issues such as the availability of a local computer with the appropriate software, the availability of a local (colour) printer for generation of hard copies, and the clinician’s familiarity with the software tools needed, may preclude this electronic method’s widespread adoption. Clinical Drawings Electronic Drawing

9. Legends Cervical tumour is represented by a red border or structure in the colour legend, or by a border filled with oblique lines in the background lines legend. Vaginal tumour extension is represented by a green border or structure in the colour legend, or by a border filled with vertical lines in the background lines legend. Parametrial extension is represented by a blue border or structure in the colour legend, or by a border filled with horizontal lines in the background lines legend. Rectum or bladder involvement is represented by a yellow border or structure in the colour legend, or by a border filled with crossed lines in the background lines legend. Tumour is presumed to be infiltrative, and with the exception of parametrial extension, can be additionally designated as exophytic using an irregularly shaped border.

10. Colour Legend Cervix Vagina Parametria Rectum or Bladder Infiltration Exophytic } May be additionally defined as:

11. Cervix Vagina Parametria Rectum or Bladder Infiltration Exophytic } May be additionally defined as: Background Lines Legend

12. / / dd/mm/yy Signature w = __ _ cm h = __ _ cm t = __ _ cm Vagina Involvement = _ _ cm h t w Infiltrative Exophytic Cervix Vagina Parametria Rectum or Bladder Clinical Drawing Patient: EBRT Gy At Brachytherapy At Diagnosis

13. / / dd/mm/yy Signature w = __ _ cm h = __ _ cm t = __ _ cm Vagina Involvement = _ _ cm EBRT Gy h t w Infiltrative Exophytic Cervix Vagina Parametria Rectum or Bladder Clinical Drawing Patient: At Brachytherapy At Diagnosis

14. Electronic Drawing Tools The drawings can be created and modified electronically using common Powerpoint © tools. Click on the individual cartoon to select it:

15. Electronic Drawing Tools After selecting a cartoon, a right click on the cartoon brings up a menu. After clicking on the Copy option, a right click of the cursor on any open area will bring up a second menu, with a Paste option. Clicking on the Paste option will place a copy of the cartoon, which can then be dragged and modified to create the drawing:

16. Electronic Drawing Tools You can change the size of the cartoon by placing your mouse over one of the corner resizing handles that appear as white circles. The mouse cursor will change to a two-headed arrow. Dragging the corner handle to resize the picture will retain its proportions:

17. Alternatively, dragging a side handle will change the size of the cartoon in that direction: Electronic Drawing Tools

18. For finer adjustments to the cartoon, a right click on the cartoon reveals the Edit Points tool. This tool allows you to modify the cartoon by adjusting individual points that make up the perimeter of the cartoon:

19. Any individual edit point can be clicked and dragged to fine tune and individualise the drawing. The cursor takes on the appearance below when the point is active and moveable: Electronic Drawing Tools

20. Examples of Clinical Drawings The different sample drawings reflect different stages, patterns of growth, and extent of disease. Stages IB to IVA are illustrated. Clinical tumour drawings should depict the disease in three dimensions and provide a clear view of the characteristics of the disease. Descriptions are based on visualisation, palpation, and imaging findings. Measurements of tumour dimensions are illustrated. For the purposes of illustration, the clinical drawings are followed by a written description of the drawing.

21. h t w = 1.8 cm h = 2.0 cm t = 1.5 cm w At Diagnosis X At Brachytherapy Dose of EBRT Gy 1.8cm 1.5cm 2cm IB1 Vagina: cm Case I dd/mm/yy / / Signature

22. IBI - At Diagnosis Cervix: tumour at the posterior and right lip, from 5 to 10h Vagina: not involved Parametria: not involved Case I

23. h t w = 0.8 cm h = 1.0 cm t = 0.5 cm w X Dose of EBRT Gy 0.8cm 0.5cm 1.0cm IB1 Vagina: cm 45 Case I / / dd/mm/yy Signature At Diagnosis At Brachytherapy

24. IBI - At Brachytherapy Good response Cervix: residual tumour from 7 to 9h Vagina: not involved Parametria: not involved Case I

25. h t w = 5.8 cm h = 7.5 cm t = 5.8 cm w X Dose of EBRT Gy 5.8cm 7.4cm IB2 Vagina: cm h Case II / / dd/mm/yy Signature At Diagnosis At Brachytherapy

26. IBII - At Diagnosis Cervix: large exophytic tumour involving the whole cervix, and protuding to almost 2/3 of the vagina, which is not infiltrated. Lateral fornices not visualised in the specular view, but not infiltrated at palpation, and MRI Vagina: not involved Parametria: not involved Case II Note: since the tumor has a large caudal extension, h (height) has to be measured along its‘ axis on the sagittal view of MRI, and also on the coronal view, besides physical exam

27. h t w = 3.2 cm h = 3.6 cm t = 3.5 cm w X Dose of EBRT Gy 3.2cm 3,5cm 3,6cm IB2 - exophytic 41.4 Vagina: cm Case II / / dd/mm/yy Signature At Diagnosis At Brachytherapy

28. IBII - At Brachytherapy Good response: Cervix: residual tumour still involving the whole cervix, with practically no extension to vaginal space. Fornices well visualised, and with no disease Vagina: not involved Parametria: not involved Case II

29. h t w = 3.8 cm h = 2.5 cm t = 4.0 cm w X Dose of EBRT Gy 3.8cm IIA 4.0cm 2.5cm Vagina: 1.5 cm Note: extension of vaginal involvement is specified separately, and should not be included in h Case III / / dd/mm/yy Signature At Diagnosis At Brachytherapy

30. Case III IIA - At Diagnosis Cervix: tumour involving cervix from 2 to 12h. External os not visualized Vagina: involvement of right, and posterior fornices, from 5 to 11h, to a maximum extension of 1.5 cm Parametria: not involved

31. h t w = 1.0 cm h = 1.0 cm t = 1.0 cm w Dose of EBRT Gy 0.5cm IIA 1.0cm Vagina: 0.3 cm Note: the small extension of vaginal involvement can be measured only on clinical exam. In this case, it can be included in w. Case III 45 / / dd/mm/yy Signature At Diagnosis At Brachytherapy X

32. Case III IIA - At Brachytherapy Good response: Cervix: residual tumour at right/posterior lip, from 7 to 8h Vagina: only a small extension to the right fornix, contiguous with residual tumour Parametria: not involved

33. h t w = 4.5 cm h = 5.0 cm t = 4.2 cm w X Dose of EBRT Gy IIB 4.5cm 4.2cm 5.0cm Vagina: 2 cm Case IV / / dd/mm/yy Signature At Diagnosis At Brachytherapy

34. Case IV IIB - At Diagnosis Cervix: exophytic and infiltrative tumour involving almost the whole cervix, preserving only a small portion of the left anterior lip, with bulky endocervical extension Vagina: exophytic lesion involving right and posterior fornices, with 2 cm extension Parametria: proximal infiltration of right parametrium

35. h t w = 2.0 cm h = 2.0 cm t = 1.5 cm w X Dose of EBRT Gy IIB 1.7cm 1.5 cm 2.0cm Vagina: cm Case IV 45 / / dd/mm/yy Signature At Diagnosis At Brachytherapy

36. Case IV IIB - At Brachytherapy Good response: Cervix: residual non exophytic tumour, in the right/posterior lip, from 5 to 10h Vagina: not involved Parametria: not involved

37. h t w = 7.5 cm h = 4.7 cm t = 4.8 cm w X Dose of EBT Gy IIIA Vagina: 7 cm 7.5cm 4.8cm 4.7cm 2cm from urethra 4cm from urethra 5cm 7cm Case V dd/mm/yy / / Signature At Diagnosis At Brachytherapy

38. Case V IIIA - At Diagnosis Cervix: exophytic tumour involving the whole cervix Vagina*: anterior (lower third, 7 cm), and right lateral (middle third, 5 cm) walls Parametria: distal involvement of the right; proximal of the left *Note: lateral vaginal involvement does not reach lower 1/3. Largest dimension should be reported, in this case, at the anterior wall. Additional measurements from the urethral os help to better understand tumour, and treatment.

39. h t w = 6.0 cm h = 4.0 cm t = 4.5 cm w X Dose of EBRTGy IIIA Anterior vaginal wall Vagina: 4 cm 6.0cm 4.5cm 4.0cm 4cm Case V 45 dd/mm/yy / / Signature At Diagnosis At Brachytherapy

40. Case V IIIA - At Brachytherapy Partial or Bad response: Cervix: partial regression of the tumour, mainly the exophytic component. Left posterior lip not involved Vagina: anterior wall with disease extending for 4 cm Parametria: small regression but still distal involvement at right; proximal at left

41. h t X Dose of EBRT Gy IIIB Vagina: 5 cm w = 9.0 cm h = 6.0 cm t = 5.0 cm 9.0cm 5.0 6.0cm w Note: vagina and parametria not included in h Case VI dd/mm/yy / / Signature At Diagnosis At Brachytherapy

42. Case VI IIIB - At Diagnosis Cervix: large exophytic tumour preserving only a small part of posterior lip, with cranial infiltration of the whole cervix Vagina: right lateral wall with exophytic lesion involving almost 2/3 of the vagina (5 cm) Parametria: right with distal infiltration; left to pelvic wall Case VI

43. h t X Dose of EBRTGy IIIB Vagina: 5 cm w = 6.8 cm h = 4.2 cm t = 4.5 cm 6.8cm 4.5cm 4.2cm w Note: parametria not included in h. Case VI 50.4 dd/mm/yy / / Signature At Diagnosis At Brachytherapy

44. Case VI IIIB - At Brachytherapy Bad response: Cervix: tumour infiltrating anterior lip, with persistence of the extensive endocervical component Vagina: not involved Parametria: partial tumour regression, with right and left distal infiltration, not reaching pelvic wall

45. h t w = 8.0 cm h = 6.0 cm t = 6.5 cm X Dose of EBT Gy Vagina: 5 cm 8.0cm 6.5cm 6.0cm w Case VII dd/mm/yy / / Signature At Diagnosis At Brachytherapy IVA - Bladder

46. Case VII IVA - At Diagnosis Cervix: extensive exophytic tumour Vagina: fornices completely involved by disease, exophytic in the anterior wall until middle 1/3 (5 cm). Paracolpus partially infiltrated bilaterally Parametria: right infiltrated to pelvic wall; left distal Bladder: invasion of the posterior wall

47. h t w = 7.0 cm h = 5.0 cm t = 5.0 cm X Dose of EBRTGy IVA - Bladder Vagina: 2.5 cm 7.0cm 5.0cm w Case VII 45 dd/mm/yy / / Signature At Diagnosis At Brachytherapy

48. Case VII IVA - At Brachytherapy Poor response: Cervix: exophytic tumour in the anterior lip. External os visible Vagina: exophytic lesion in the anterior fornix with 2.5 cm extension. Lateral and posterior fornices with no visible disease, but with bulging due to cervical tumour extension Parametria: distal infiltration at right, minimal proximal infiltration at left Bladder: persistence of posterior bladder wall invasion at MRI

49. h t w = 6.0 cm h = 5.5 cm t = 6.0 cm X Dose of EBRT Gy Vagina: cm 6.0cm 5.5cm w Case VIII dd/mm/yy / / Signature At Diagnosis At Brachytherapy IVA - Rectum

50. Case VIII IVA - At Diagnosis Cervix: extensive infiltrative tumour of the cervix, and endocervix Vagina: bulging of right fornix by tumour. Mucosa not infiltrated Parametria: right half infiltrated; left to proximal third Rectum: involvement of anterior wall

51. h t w = 5.0 cm h = 5.0 cm t = 5.0 cm X Dose of EBRT Gy Vagina: cm 5.0cm IVA - Rectum w Case VIII 45 dd/mm/yy / / Signature At Diagnosis At Brachytherapy

52. Case VIII IVA - At Brachytherapy Poor response: Cervix: persistence of infiltrative tumour of the cervix, and endocervix Vagina: bulging of right fornix by tumour. Mucosa not infiltrated Parametria: proximal infiltration of right and left Rectum: not involved clinically or on MRI

53. Special Case To Illustrate a bulky cervical tumour where the tumour bulges towards the vaginal, bladder and rectal walls, but these structures are not involved.

54. h t w = 5.8 cm h = 6.4 cm t = 6.0 cm w X Dose of EBRT Gy IB2 - Bulky Vagina: cm 5.8cm 6.0cm 6.4cm Case IX dd/mm/yy / / Signature At Diagnosis At Brachytherapy

55. Case IX IBII - At Diagnosis Cervix: infiltrative bulky tumour involving the whole cervix Vagina: not involved Parametria: not involved Bladder and rectum: not involved *Note: tumour volume pushes the parametria laterally. At physical exam it may feel involved, but this can be better judged by MRI